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- 2026-04-09 14:41:31
- Policy
- ₩176.5 bil was spent on atopic dermatitis every year
- by Kim, Jung-Ju Aug 16, 2023 05:37am
- The National Health Insurance medical expenditures spent by patients with atopic dermatitis have risen every year to record KRW 176.5 billion last year. This is a 114.4% rise in 5 years. By age group, patients in their 20s accounted for 34.1% of the total expenditures, followed by those in their 30s (18.9%), then those in their 40s (11.8%). The National Health Insurance Service analyzed the NHI treatment data for atopic dermatitis from 2018 to 2022 using NHI data. The number of patients who received treatment for atopic dermatitis had increased from 92,0487 to 971,116 (5.5%↑), at an average annual increase rate of 1.3%. The number of male patients increased by 0.5% (1982↑) from 438,756 in 2018 to 440,738 in 2022, and female patients increased by 10.1% (48,647↑) from 481,731 in 2018 to 530,378 in 2022. Atopic dermatitis patients by gender (2018-2022) Looking at the composition of the number of patients treated for atopic dermatitis by age group, the most number of patients treated were 9 years old or younger, accounting for 28% (271,613) of all those treated in 2022 (971,116). Those in their 20s accounted for 16.7% (161,711), followed by teenagers accounting for 15.5% (150,837 people). Among male patients, those under the age of 9 accounted for the highest proportion (32.3%), followed by those in their teens (17.3%), then those in their 20s (16.4%). Among female patients, those under the age of 9 accounted for the highest proportion (24.4%), followed by those in their 20s (16.8%), then those in their teens (14.0%). When looking at the number of patients with atopic dermatitis per 100,000 population by year, the number rose from 1,802 in 2018 to 1,889 in 2022 (4.8%). Health insurance treatment costs for patients with atopic dermatitis increased by 114.4% (94.2 billion won) from 82.3 billion won in 2018 to 176.5 billion won in 2022, with an average annual increase of 21%. NHI expenditures spent to treat atopic dermatitis increased by 114.4% (KRW 94.2 billion) from KRW 82.3 billion in 2018 to KRW 176.5 billion in 2022, at an average annual increase of 21%. As of 2022, when looking at the proportion of NHI medical expenditures spent on patients with atopic dermatitis by age, those in their 20s accounted for the most at 34.1% (KRW 60.2 billion), followed by those in their 30s with 18.9% (KRW 33.3 billion) and those in their 40s with 11.8% (KRW 20.8 billion). By gender, both males and females in their 20s accounted for the most, accounting for 37.2% (KRW 40.3 billion) and 29.1% (KRW 19.9 billion), respectively.
- Policy
- Will it be possible to cover 'obesity drugs'?
- by Lee, Jeong-Hwan Aug 16, 2023 05:37am
- Attention is focusing on whether health insurance coverage standards for obesity treatment drugs, which are classified as non-reimbursed drugs that are not covered by health insurance, can be established. The Ministry of Health and Welfare announced that it had started discussions with the Korean Society of Obesity to discuss the necessity of reimbursement for obesity treatment and treatment and a reimbursement model to solve the problem of the domestic obesity rate. However, specific details, such as when and which obesity treatment and treatment will be applied, have yet to be confirmed. On the 14th, the Ministry of Health and Welfare submitted such a plan to the National Assembly regarding the reimbursement of medical treatment and treatment to solve the domestic obesity rate. The Health and Welfare Committee of the National Assembly requested the Ministry of Health and Welfare to unify the BMI (Body Mass Index) standard, which is the criterion for determining obesity and urged policies related to the introduction of drug treatment and reimbursement of obesity prevention medical services for severely obese people with a BMI of 30 kg/㎡ or more. Currently, the Ministry of Food and Drug Safety has changed the approval requirements and safe use standards for narcotic appetite suppressants to a BMI of 30 kg/㎡ or higher, but the Ministry of Health and Welfare has yet to establish a unified standard for obesity. The Ministry of Health and Welfare explained that in order to solve this problem, a meeting was held to discuss the need for unification of obesity BMI standards and the direction of adjustment. However, it was added that the need for further discussion was confirmed due to differences in opinions on key considerations such as the appropriate BMI standard for obesity, risk of death, risk of disease, life expectancy, and healthy life span. The Ministry of Health and Welfare plans to continue conducting additional reviews on the necessity and direction of the unification of obesity standards in the future. The Ministry of Health and Welfare announced that it would seek solutions together with academic societies regarding the payment of obesity treatment and treatment drugs. The Society for Obesity pointed out that there are frequent cases in which obese patients stop prescribing drugs due to economic burden through a 'survey on awareness and status of obesity treatment' last year, and emphasized reimbursement. Drugs used to treat obesity have obtained market approval from psychotropic narcotic drugs to GLP-1 analogs modified for diabetes treatment. Currently, in the case of obesity treatment, all treatments and medications except for surgical treatment for extremely overweight and extremely obese patients are not covered. The Ministry of Health and Welfare said, "We are discussing the necessity of reimbursement for obesity treatment and the reimbursement model with the obesity society."
- Company
- Companies seek to invalidate Jardiance’s unlisted patents
- by Kim, Jin-Gu Aug 16, 2023 05:37am
- Generic companies have begun challenging the unlisted patent of Jardiance (empagliflozin), an SGLT-2 inhibitor-class diabetes treatment. From the generic companies’ perspective, they must overcome Jardiance’s unlisted patents to release their generics early, just after Jardiance’s substance patent expires in 2025. According to industry sources on the 14th, Chong Kun Dang and Genu Pharma recently filed an invalidation trial against Boehringer Ingelheim on Jardiance’s use patent (10-1463724). The patent is not listed on the Ministry of Food and Drug Safety’s Green List. The patent, which is set to expire in November 2027, covers not only the treatment of diabetes but also the use of Jardiance for the treatment of obesity and metabolic syndrome. Currently, only 2 Jardiance patents are listed on the Ministry of Food and Drug Safety’s Green List: a substance patent (10-1249711) that expires in October 2025 and a crystalline patent (10-1174726) that expires in December 2026. Previously, generic companies have succeeded in avoiding Jardiance’s crystalline patent. In 2018, 52 companies, including Chong Kun Dang, filed a trial to confirm the passive scope of rights of the Jardiance’s crystalline patent against Boehringer Ingelheim in 2018 and won in May of the following year. In the case of the substance patent, Dong-A ST failed to invalidate the patent. Based on the results, generic companies planned to release Jardiance generics upon the expiry of the drug’s substance patent in March 2025. However, Jardiance’s unlisted patents are holding the companies back. Even if they do not overcome unregistered patents, there is no problem for patent challengers receiving approval for their generics. However, if they really release their drugs onto the market, they are at a high risk of patent infringement. If a product is released without overcoming an unlisted patent, there is a high possibility that the original company will file a patent infringement lawsuit and an application for a provisional injunction to prohibit the sales of the product. In addition, if a company loses the patent infringement lawsuit, a claim for damages is inevitable. The problem is that it is difficult to know exactly how many unlisted patents exist for Jardiance. First of all, it is speculated that there will be 1 or 2 more unlisted patents based on NHIS analysis. From the perspective of the generic companies, they are faced with the task of overcoming unlisted patents without knowing how many really exist, to release their latecomer drugs.
- Company
- [Reporter’s View] Trending CSO sales and their treatment
- by Lee, Seok-Jun Aug 16, 2023 05:37am
- Contract sales organizations (CSOs) are trending in the pharmaceutical industry. The Ministry of Food and Drug Safety announced that 45% of the 195 companies it had surveyed use CSO companies. When limiting the subjects to small-to-mid-size companies, the industry expects the rate to far exceed 70%. The Top 10 pharmaceutical companies in Korea are also preparing to use SCO sales for their products. Kyung Dong Pharma also chose to outsource sales to CSOs at the beginning of the year. The company laid off 180 of the 250 sales representatives. As a result, the number of employees (excluding fixed-term workers) decreased from 569 at the end of last year to 397 by the end of Q1 this year. Company K also announced plans to start using CSO for sales from 2H this year. The company will use CSOs instead of its local workforce. The change in the company’s number of employees is expected to be reflected in the company’s Q3 report. However, two major challenges must be addressed for the trending CSO sales to go mainstream in Korea. The first is in preserving the sustainability of each company’s management. Pharmaceutical companies that introduce the CSO system undergo major changes. Their number of employees plummet and commissions paid out to the CSOs soar. Performance fluctuates in this process. Since the companies have never used such methods before, if they fail to implement the CSO system well in the beginning, it can lead to poor performance. Therefore, the company should share its revamping process and share their future management policies. Kyung Dong Pharma’s case is worth referring to. After switching to a CSO system earlier this year, the company distributed press releases even though it marked a deficit for 2 consecutive quarters. This was unusual considering how performance reports are mainly released by companies that show an improvement in their performance, such as record-high sales. However, the press release showed the reason why. Through the release, the company explained the reason for the deficit and the company’s future management direction. “The decline in profits in 1H is within the expected range due to the company’s introduction of a marketing agency system. We will do our best to turn a profit in the 2H this year by launching combination drugs and new products, increasing defense of drugs subject to price cuts, and strengthening sales competitiveness.” Although the message was simple, from an investor's point of view, the press release provided ‘thankful information’ on when to expect a surplus and how the company is planning to overcome its deficit. The second task that remains for the CSO sales culture to settle in Korea is managing the point organizations exposed to rebates. This is an issue we are all already aware of, and it is now the time to act on it. Companies that are using CSOs are on the up and rise. The ‘Increase in commissions=increase in sales” settled as a formula. Some companies are investing more than half of their sales revenue as commissions to drive sales through CSOs. However, the management of the CSOs that are made up of point organizations, remains a challenge. Some say it is virtually out of control. Some describe them as rebate windows due to overheated commission competitions. This is why the CSO reporting system should be legislated with a soft landing. Although CSO legislation is an option, in the end, it all depends on the will of the pharmaceutical company owners. The CSO reporting system only suppresses rebates but is not a fundamental measure. If CSO is the trend, it is necessary to devise a way to use CSOs without triggering a dumping war based on the owner's determination to fight cleanly. This is also connected to ESG management. The patent for the blockbuster antidiabetic ‘Januvia (sitagliptin),’ worth KRW 110 billion a year, is set to expire in a month. It is expected that sales competition will intensify around CSOs for the sales of generic products. Rebate concerns are rising. For CSOs, which is settling as a method of pharmaceutical sales, to make a soft landing in Korea, the owner's will for the clean competition will be ever the more important. The company should also share its prediction of its business sustainability to its shareholders consistently. These two will be essential for companies that seek to use CSO sales.
- Company
- Cinqair draws attention to entry into reimbursement rights
- by Eo, Yun-Ho Aug 16, 2023 05:37am
- Attention is focusing on whether Cinqair, an asthma antibody drug, will be listed on the list of insurance benefits after six years of domestic approval. According to related industries, Teva Handok is negotiating with the NHIS for the listing of Cinqair, a monoclonal antibody targeting interleukin (IL)-5. Unlike competitive drugs, positive results are expected as the general listing process is in progress, rather than RSA. AstraZeneca Korea's Fasenra and GSK Korea's Nucala, two interleukins (IL)-5 antagonists with the same mechanism as Cinqair, are aiming to enter reimbursement rights through RSA, but no progress has been made in discussions yet. These drugs reduce the number of eosinophils, a type of white blood cell involved in the induction of asthma. Cinqair was approved in Korea for the first time in 2017 as a maintenance treatment for adult patients with severe eosinophilic asthma (blood eosinophil counts at the start of treatment: 400 cells/μL or more) that is not adequately controlled by existing treatments. After that, after the non-payroll launch in 2018, it tried to be listed but eventually failed. The efficacy of Cinqair was confirmed in five placebo-controlled trials demonstrating the efficacy and safety profile of Cinqair 3 mg/kg in 1028 adults and adolescents with asthma who were not managed with baseline therapy. In three phase 3 clinical programs in asthma patients with high blood eosinophil levels, Singcare reduced the frequency of asthma exacerbations by up to 59% and significantly improved lung function, symptoms, and asthma-related quality of life. In addition, Cinqair attracted attention by disclosing the results of post-hoc analysis, which selected only stage 4 and 5 patients among all patients who participated in phase 3 clinical trial. Cinqair lowered the degree of clinical asthma exacerbation in patients with stages 4 and 5 according to the GINA guidelines by 53% and 72%, respectively, compared to the placebo group, and increased FEV1 (forced expiratory volume in 1 second) by 103ml in stage 4 patients and by 237ml in stage 5 patients. It was confirmed that the benefit was greater in stage 5 patients. Meanwhile, there are no registered drugs for severe asthma since Novartis Korea's Xolair entered reimbursement rights in 2020. In terms of the disease domain of 'asthma', they seem identical, but three drugs and Xolair are prescribed for allergic asthma. There are differences in the details of indications. However, according to the government's standards, Xolair became the target of comparison, and the price of the drug was unbearable for three new biologics.
- Company
- the era of Lung cancer cure
- by Jung, Sae-Im Aug 14, 2023 05:21am
- The third-generation EGFR-targeting anti-cancer drug Tagrisso (Osimertinib) has left a unique record in non-small cell lung cancer. Significant improvement was achieved in adjuvant therapy after surgery, and it was also proven that survival time could be extended. This is an area that previous TKI drugs have failed to overcome. Tagrisso has already demonstrated that it can reduce the risk of recurrence or death by about 80% through the phase 3 clinical trial of ADUARA three years ago. Since then, people's attention has been focused on overall survival. I wondered how much longer actual patients could live if Tagrisso was used early. The results were revealed at ASCO 2023 held this year. As a result of analyzing the overall survival rate at 5 years, the risk of death in the Tagrisso group was 88%, compared to the placebo group (78%), and the risk of death was reduced by 51% (HR=0.49). The overall survival improvement of Tagrisso was consistently shown in the sub-analysis according to sex, age, race, smoking history, and adjuvant chemotherapy. Professor Han Ji-yeon, National Cancer Center.\ Han Ji-yeon, professor of hemato-oncology at the National Cancer Center, said, "Following the primary evaluation variable, DFS, OS improvement also showed data of HR of 0.49." It was groundbreaking in that it opened." The reason for administering adjuvant chemotherapy after surgery in early patients is to minimize the possibility of recurrence by preventing very small tumors from remaining in the early stage. However, the cytotoxic anticancer drugs used before Tagrisso were not very effective in reducing recurrence. According to Professor Han, cytotoxic anticancer drugs do not respond well to patients with EGFR-mutated lung cancer, so more than half suffer recurrence. With the introduction of Tagrisso, the recurrence rate of patients dropped significantly from 3% in the first year to 10% in the second year. At 3 years, 78% of patients still had no recurrence of cancer. Tagrisso ADAURA OS graph (source ASCO) According to the sub-analysis, the risk ratio was slightly higher in the L858R patient group than in the exon 19 deletion patient group among EGFR mutation types, at 0.68, but still proved the benefit of Tagrisso. Regarding this, Professor Han explained, "The receptor mutation structures of the exon 19 defect and L858R are different, but compared to the L858R mutation, the exon 19 defect has a structural feature that TKI adheres well." Professor Han explained, "Also, the L858R mutation rate was relatively higher in Asians, so the results were better in non-Asians. There is no way to solve the difference due to the characteristics of genetic mutations biologically." Following the DFS risk ratio of 0.17, the primary endpoint, the OS risk ratio of 0.49 was added, and Professor Han emphasized that Tagrisso's position in postoperative adjuvant therapy has become more solid. In addition, he emphasized the need to change the perception of reimbursement registration for adjuvant therapy. Earlier, in a discussion session on adjuvant treatment after Tagrisso surgery at ASCO, she said, "10% of patients who would not have survived 5 years without Tagrisso are alive." Then, an opinion was raised that “global support is needed to provide support for early screening and treatment so that the gap and inequality in global access to effective cancer treatment does not deepen.” In Korea, Tagrisso can still be used as a reimbursement only for the second or higher treatment only for progressive and metastatic cases, leaving a large gap with the global market. Professor Han said, “It has been about five years since Tagrisso was approved in Korea, but it is not yet covered by insurance as a first-line treatment. Considering the global trend, discussing first-line treatment benefits is too late.” If it goes well, I think that Tagrisso should be provided even in the environment of early lung cancer adjuvant therapy, which opened the 'era of lung cancer cure'," she emphasized.
- Company
- First immuno-oncology drug for endometrial cancer?
- by Eo, Yun-Ho Aug 14, 2023 05:21am
- Attention is rising on whether the first immuno-onoclogy treatment option will be approved for endometrial cancer in Korea. According to industry sources, GSK Korea’s PD-1 inhibitor Jemperli (dostarlimab) has passed review by the Health Insurance Review and Assessment Service’s Drug Reimbursement Evaluation Committee and is soon to start drug pricing negotiations with the National Health Insurance Service. The reimbursement process for the drug has been progressing relatively quickly since its approval in December, and as the drug seeks to be listed for a different indication from existing drugs, whether it will derive positive results is a focus of interest. For the benefit of these patients, GSK has been offering an Expanded Access Program (EAP) in 15 major medical institutions in Korea since earlier this year before filing for reimbursement. Unlike other immuno-oncology drugs, Jemperli is the first drug indicated for the treatment of mismatch repair deficient (dMMR) recurrent or advanced endometrial cancer that has progressed on or following prior treatment with a platinum-containing chemotherapy regimen. This was why the company decided to first provide treatment opportunities to those patients in need. Jemperli’s approval was based on the cohort A1 analysis results of Phase I multicohort GARNET trial that included a cohort of patients with relapsed or advanced dMMR/MSI-H endometrial cancer who progressed on or following prior treatment with a platinum-containing regimen. In particular, this study had the largest cohort among PD-1 inhibitor monotherapy studies for dMMR/MSI-H endometrial cancer patients among those that have been conducted so far. The major efficacy outcome measures of the study were Objective Response Rate (ORR) and Duration Of Response (DOR) as determined by a Blinded Independent Central Review (BICR) according to (Response Evaluation Criteria Solid Tumors) RECIST v 1.1. As a result of analyzing a total of 108 patients with a median follow-up of 16.3 months, Jemperli demonstrated durable antitumor activity with a manageable safety profile. In the cohort, the ORR was 43.5% and the median DOR was not yet reached. Disease Control Rate (DCR) was 55.6%, and the proportions of responses lasting 6 and 12 months were 97.9% and 90.9%, respectively. Endometrial cancer develops in the endometrium, the inner lining of the uterus, and accounts for the majority of cervical cancer. Roughly, 1 out of 4 endometrial cancer patients are diagnosed to be in the advanced stage or experience recurrence, and patients whose disease recurs after platinum-based chemotherapy have limited treatment options.
- Company
- With the BPH drug Duodart be the first combo to succeed?
- by Kim, Jin-Gu Aug 14, 2023 05:21am
- Pic of Duodart GSK’s benign prostatic hyperplasia (BPH) drug ‘Duodart (dutasteride+tamsulosin)’ has been making rapid growth in the outpatient prescription market in Korea. Until now, the market for combination drugs in the field of urology was considered barren. Unlike other chronic disease areas, combination drugs are rare in the area. Companies have been dropping the development of their combo drugs shortly before commercialization due to low marketability. This is why the industry is focused on the success of Duodart’s soft landing in the Korean market. If Duodart paves the way and makes success as a combination drug in the field of urology, the industry believes it will encourage the development of other combination drugs in the market. Duodart’s annual sales to rise to record KRW 10 billion in its second year of release According to the market research institution UBIST on the 11th, GSK’s Duodart posted outpatient prescriptions of KRW 3.9 billion in Q2 this year This is a 4.5 time rise from the KRW 0.9 billion the drug had made in Q2 last year. Duodart is a combination of dutasteride tamsulosin. Both ingredients are used to treat BPH. The company received approval for the drug in May 2021 and released the drug with reimbursement in March last year. Duodart’s sales had grown rapidly upon its release. Its sales rose from KRW 0.9 billion in Q2 last year to KRW 1.5 billion in Q3, then to KRW 2.8 billion in Q1 this year, and KRW 3.9 billion in Q2 this year. At this pace, its sales will likely exceed KRW 10 billion by the end of this year. ▲ Quarterly prescription of Duodart (Unit: KRW 0.1 bil, Source: UBIST) The pharmaceutical industry is keenly eying the success potential of Duodart because the market for combination drugs in urology was considered barren until now. Although the patent for BMH drugs such as tamsulosin, finasteride, dutasteride, OAB drugs such as mirabegron, solifenacin, and erectile dysfunction drugs sildenafil and tadalafil had expired until now, news of combination products being released that use these various off-patent ingredients are rare in Korea. Hamni Pharm’s tamsulosin+tadalafil combination drug ‘Gugutams’ i which was released in 2014, is virtually the only combination drug that is available in the market. However, Gugutams fell short of market expectations, as it has been posting annual sales that range around KRW 2 billion. The industry analysis is that the market has a strong loyalty for original drugs. Also, its total market size is small compared to those of hypertension, diabetes, or hyperlipidemia, and as nearly 100 generics are already available for each ingredient, the marketability of developing combination drugs is not high compared to the input cost. Duodart shows rapid growth...Will this spark the development of combo drugs in urology? This was why so many companies had discontinued their development of combination drugs in the field. Pic of Gugutams, the only urology combo drug available in the market Ildong Pharmaceutical, Yungjin Pharm, and Chong Kun Dang, which had started the development of their tamsulosin+tadalafil at the same time as Hanmi Pharm, had all discontinued the development of their respective combinations. Ildong Pharmaceutical had also jumped into the development of a tamsulosin+solifenacin combination for BPH but decided not to release the product just before commercialization. Ildong Pharmaceutical started Phase III trials for its combination drug in 2015 and completed the trial in 2019, but decided not to release the drug after internal discussions. Similarly, Jeil Pharmaceutical had started developing a combination drug with the same ingredients as Ildong but did not apply for marketing authorization for its drug even after completing the Phase III clinical trial in 2019. The industry interprets that the company had stopped development of the combination. However, attention is focused on whether the sales growth of Duodart will bring about change in this atmosphere as it hints at the possibility of success in the field of urology as a combination drug. Currently, there are four to five clinical trials in progress for combination drugs in urology. They are combination drugs for BPH+erectile dysfunction or combination drugs for BPH+OAB. DOngkook Pharmacuetical recently completed Phase III trials for its combination of dutasteride and tadalafil. Yuyu Pharma also started developing a combination drug with the same ingredients. Although the plan for its Phase III trials was approved in 2018, the need to change its formulation had been raised before its initiation, and the company decided to restart its development from Phase 1. Development of a combination drug that treats BPH and OAB at the same time is also in full swing. Kyungdong Pharm and DongKoo Bio&Pharma have started Phase III trials at about the same time and are competing to develop their combination drugs. DongKoo Bio&Pharma also received approval to initiate a Phase III clinical trial for its tamsulosin+mirabegron combination. Kyungdong Pharmaceutical received approval to initiate Phase III trials using the same combination 2 months later. In addition, CTCBio has completed its Phase III trial for its clomipramine+ sildenafil combination, as a treatment for premature ejaculation and erectile dysfunction at the same time, and is preparing to apply for its marketing approval in Korea.
- Company
- Oral SMA drug Evrysdi prescribed at tertiary hospitals
- by Eo, Yun-Ho Aug 14, 2023 05:21am
- The oral spinal muscular atrophy (SMA) treatment ‘Evrysdi’ may now be prescribed at tertiary hospitals in Korea. According to industry sources, Roche Korea’s SMA treatment Evrysdi (risdiplam) passed the drug committee (DC) reviews at the Big 5 tertiary hospitals in Korea - Samsung Medical Center, Seoul National University Hospital, Seoul, Asan Medical Center, Seoul St.Mary’s Hospital, and Sinchon Severance Hospital – and many other major medical institutions including the Gangnam Severance Hospital, Pusan National University Hospital at Yangsan, and Yongin Severance Hospital. As Roche is currently in the final negotiation stage with the National Health Insurance Service for Evrysdi’s reimbursement, the industry believes Evrysdi’s reimbursement listing will quickly turn into prescriptions, if it is granted reimbursement. Evrysdi was first approved in Korea in November 2020. The company applied for the reimbursement listing of its drug in July 2022 but the agenda had long been pending at the Drug Reimbursement Standard Subcommittee stage after the committee deferred making decisions. The agenda finally passed the Drug Reimbursement Standard Committee review in June this year. Whether Evrysdi will be able to complete the reimbursement listing process until the end of this time and settle as an oral treatment option for SMA in Korea remains to be seen. As the first oral option introduced in the field of SMA, Evrysdi has the advantage of allowing customized prescriptions for patients according to age and weight. Currently, Biogen’s ‘Spinraza (nusinersen)’ and Novartis's Zolgensma (onasemnogene abeparvovec-xioi) are listed for reimbursement in Korea. Meanwhile, Evrysdi’s efficacy has been demonstrated through the FIREFISH trial that was conducted on infants 2 months to 7 months of age, and the SUNFISH trial that was conducted on children and adults of 2 years to 25 years of age. In the SUNFISH trial that was conducted on 180 Type 2 or 3 SMA patients, Evrysdi improved motor function at Month 12, as measured by the Motor Function Measure 32 (MFM-32) score from baseline. Also, in the FIREFISH trial that was conducted on infants 2 to 7 months of age with Type 1 SMA, 88% of the patients that were administered Evrysdi for 2 years survived the 2 consecutive years without ventilator support. Based on the Bailey Infant Development Test (BSID-III) that measures infant development and motor activity, 59% of the infants that were administered Evrysdi were able to sit without support for at least 5 seconds. Also, 65% of the infants were able to control their necks for 1 year, 29% were able to turn on their buttocks, and 30% were able to stand with support.
- Company
- Could Lilly Retatrutide be a game-changer for obesity drug?
- by Nho, Byung Chul Aug 14, 2023 05:21am
- Attention is focusing on whether Eli Lilly can commercialize another blockbuster drug in the global obesity drug market worth 13 trillion won by entering phase 3 clinical trials for new drug candidates, Orforglipron and Retatrutide. According to related industries, the Ministry of Food and Drug Safety approved the phase 3 clinical trial to confirm the effect of once-weekly administration of Retatrutide in obese or overweight type 2 diabetes subjects in mid-March last month. Orforglipron also recently announced the results of its phase 2 clinical trial through the American Diabetes Association and is preparing for a global phase 3 clinical trial. Both candidates are a class of glucagon-like peptide-1 (GLP-1) receptor agonists that mimic hormones produced in the gut lining, which slow down digestion and act on receptors in the brain to reduce appetite and thus promote weight loss. is a mechanism that shows Retatrutide showed a weight loss effect of 24.2% after 48 weeks in the 12mg group, the highest dose, in a phase 2 clinical trial conducted on 281 diabetic patients aged 18 to 75 years. Orforglipron showed a practical pharmacological effect on weight management in phase 2 clinical trials and is expected to be released at a lower price compared to existing treatments because it is easy to produce as a non-peptide oral tablet. Two of the existing obesity treatment drugs contain Semaglutide and Tirzepatide, which are sold under the product names of Novo Nordisk Wegovy and Lily Mounjaro, respectively. According to the announcement of the American Diabetes Association, orforglipron·retatrutide has advantages over Wegovy and Mounjaro, such as high weight loss effect, low price, and ease of administration. Obesity drugs containing Semaglutide and Tirzepatide are effective in reducing body weight and blood sugar and alleviating high blood pressure but have the disadvantage of requiring weekly injections, being difficult to manufacture, and having high production costs because they are in the form of peptides. Novo Nordisk plans to develop an oral treatment for GLP-1 series Wegovy within the year and obtain US and European approval and is expected to compete with Retatrutide. This triple agonist simultaneously activates GLP-1, GIP, and glucagon receptors. GLP-1 promotes insulin secretion to lower blood sugar, suppress appetite, and reduce the rate of food excretion from the stomach and is used as a treatment for diabetes and obesity. Lilly's GLP-1 GIP dual agonist Mounjaro confirmed a 22.5% reduction effect when administered at the highest dose of 15 mg/0.5 ml for 72 weeks in obese patients without diabetes. It is approved only as an adjunct to diet and exercise therapy.
