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- 2026-04-16 04:58:38
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- CKD top candidate for Amgen’s Evenity co-promotion partner
- by Oct 26, 2020 06:14am
- A product image of Amgen Evenity. As Amgen’s novel osteoporosis drug Evenity (romososumab) is expected to get listed for reimbursement by the end of the year, the multinational company is reportedly seeking for a co-promotion company. The current partner company for Prolia (denosumab) co-promotion, Chong Kun Dang, is considered as the strongest candidate. According to pharmaceutical industry sources on Oct. 22, Amgen is in process of searching for a South Korean co-promotion partner as they aim to receive the National Health Insurance (NHI) reimbursement within this year. The sources claim Chong Kun Dang is on top of the list. In September 2017, Chong Kun Dang signed a co-promotion deal with Amgen for other osteoporosis drug Prolia, which is still effective to this date. Prior to its reimbursement listing in October 2017, Amgen shook hands with the South Korean company to leverage the sales in Prolia. Boosted by the coverage approval and the co-promotion deal, Prolia’s sales surged soon after. The sales marked 2.4 billion won in the fourth quarter of 2017, almost doubling the initial quarterly sales at launch of 1 billion won. The quarterly sales skyrocketed to 12.3 billion won in April last year, after its reimbursement standard was expanded to first-line therapy. The cumulative sales up to the first half of 2020 reached 100.6 billion won. And because Amgen is to take the marketing strategy of introducing Evenity as a sequential combination therapy with Prolia, Chong Kun Dang is the most likely candidate. Prolia is a bone resorption inhibitor, launched earlier, and Evenity is a bone-builder and a bone resorption inhibitor. Amgen set down a therapeutic strategy to administer Evenity first to postmenopausal women fracture and men with osteoporosis at high risk for fracture (maximum 12 months), and to continue on with Prolia as maintenance therapy. In fact, their clinical trial has been conducted as a sequential therapy. Compared to the placebo group after 12 months, the Evenity group had 73 percent lower risk of new vertebral fracture. The patient group that switched to Prolia (denosumab) at year 2 after 12 months of using Evenity showed 75 percent lower risk of new vertebral fracture, compared to the placebo group switching to Prolia. Considering Evenity’s marketing strategy has to be in accordance with Prolia’s, the existing co-promotion partner Chong Kun Dang would be the most efficient option. Sources confirmed, the two companies are already in talks to expand their deals to also cover Evenity. When the final contract is inked, Chong Kun Dang is expected to initiate the co-promotion activities from next year after the novel osteoporosis drug is listed. The industry source commented, “We are anticipating to a see a positive level of synergy effect created from Evenity as Amgen and Chong Kun Dang are already in a good collaboration for Prolia.”
- Company
- Rosuzet soars despite COVID-19, Lipitor tops market again
- by An, Kyung-Jin Oct 23, 2020 09:46am
- On Oct. 23, a pharmaceutical market research firm UBIST reported a dyslipidemia treatment Lipitor defended its top spot again in the outpatient prescription market this third quarter reaching a cumulative prescription volume of 140.1 billion won. Compared to the third quarter last year at 143.1 billion won, the figure dipped 2 percent, but its prescription volume doubled Daewoong Bio’s Gliatamin’s. In 1999, Pfizer Pharmaceutical Korea launched a hyperlipidemia treatment Lipitor (atorvastatin) in the South Korean market. After its patent expired, about 130 generics were released but it has never fell below second place in the prescription drug market for over a decade. Daewoong Bio’s cognitive function enhancing choline alfoscerate, Gliatamin generated a cumulative prescription volume of 73.8 billion won and stayed at the second spot. Compared to the previous year at 70.2 billion won, the prescription volume grew by 5.1 percent. During the same time, another competitor Chog Kun Dang Gliatirin marked 63.3 billion won this third quarter and leapt by 12.4 percent. Regardless of the controversy on the choline alfoscerate efficacy and the novel coronavirus (COVID-19), the two drugs were able to maintain their prescription volume. 2020 Q3 cumulative outpatient performance rank (Unit: KRW 1 million) Source: UBIST Among the top products in the prescription drug market, Hanmi Pharmaceutical’s Rosuzet had the highest growth. For nine months, Rosuzet generated f 72.8 billion won and had a 24.3-percent surge compared to last year. Basically, the average monthly volume was over 8 billion won. Launched in the Korean market in late 2015, Rosuzet is a dyslipidemia treatment consisting of rosuvastatin and ezetimibe. Hanmi Pharmaceutical licensed in the use of ezetimibe from the patent owner MSD and allowed itself to take the generic market faster than other competitors. While the competition among rosuvastatin plus ezetimibe combination drug market is intensifying day by day, Rosuzet has been on the top of the charts with a significant gap from the competitors. Despite the difficulties in the sales and marketing activity amid COVID-19, Rosuzet’s quarterly prescription volume showed over 20 percent growth every quarter and marked a record high prescription volume. The drug kept a steady prescription volume in the second and third quarters, when the confirmed cases of COVID-19 exploded. The industry experts predict the drug’s annual prescription volume could break through the 100 billion won line. Meanwhile, the off-patent drugs had contrasting results. Boehringer Ingelheim’s hypertension combination drug Twynsta had prescription volume of 70.6 billion won and grew by 2.0 percent from last year same time, but Sanofi’s anticoagulant Plavix had a 1.2-percent dip. AstraZeneca’s dyslipidemia treatment Crestor also stepped down by 5.5 percent. But the market experts claim the fluctuating growth is not too concerning as the government has ordered stricter social distancing measures from last August and the country’s general economy was stagnant. AstraZeneca’s anticancer treatment Tagrisso (osimertinib) placed itself on the sixth place after climbing up 4.8 percent from last year and generated 65.9 billion won. The anticancer treatment is prescribed to non-small cell lung cancer patients who have developed tolerance on epidermal growth factor receptor (EGFR) tyrosine kinase inhibitors (TKIs), such as Iressa (gefitinib), Tarceva (erlotinib) and Giotrif (afatinib). Its prescription volume has been skyrocketing since its National Health Insurance (NHI) listing green lit in December 2017. Although its price is still high at 120,000 won with the reimbursement, the convenient oral drug is the only anticancer treatment found among the top prescribed drugs for outpatients. A hepatitis B treatment Viread (tenofovir disoproxil fumarate) that used to top the prescription drug market took a steep 25.9-percet fall in just within a year, raising 64.9 billion won. In the same year, the prescription volume of Bristol-Myers Squibb (BMS) Pharmaceutical Korea’s hepatitis B treatment Baraclude (entecavir) was brought down by 10.8 percent from 39 billion won to 34.8 billion won.
- Company
- Rinvoq is in the process of prescribing general hospitals
- by Eo, Yun-Ho Oct 23, 2020 09:44am
- The third JAK inhibitor Rinvoq was received for prescription in general hospital. The synergy is expected as the application of insurance benefits became visible from November. According to related industries, AbbVie Korea recently concluded a drug price negotiation between the NHIS and the oral autoimmune disease treatment Rinvoq (Upadacitinib), and listed. Applications of DC to major general hospitals including Big 5 are in progress from October. It recently concluded a drug price negotiation with the NHIS, and listed. AbbVie focused on the pace of Rinvoq's listing by accepting the weighted average price of alternative drugs because Pfizer's Xeljanz (Tofacitinib citrate) and Lilly's Olumiant (Baricitinib), which have the same mechanism, are already listed. Rinvoq's permit-reimbursement linkage system was also very useful. As a result, the drug, which was approved in Korea in June, was put on the reimbursement list in about five months. Janus kinase (JAK) inhibitors, such as Xeljanz, Olumiant, and Rinvoq, were the first oral options that proved equivalent to anti-TNF drugs in the area of autoimmune diseases, and have received a lot of attention. However, it has not yet exerted as much influence as biological agents in the market. Anti-TNF drugs and anti-interleukin drugs are also active, but the indications for JAK inhibitors were relatively narrow in areas other than rheumatoid arthritis. JAK inhibitors have potential. Xeljanz, which was first developed last year, secured additional indications such as ulcerative colitis and psoriatic arthritis, and generics, including Rinvoq, are also conducting research to expand indications for autoimmune diseases such as atopic dermatitis, Crohn's disease, and ankylosing spondylitis. Rinvoq proved its effectiveness through five phase III SELECT clinical trials (SELECT-NEXT, SELECT-BEYOND, SELECT-MONOTHERAPY, SELECT-COMPARE, SELECT-EARLY) in which 4,443 patients with moderate to severe active rheumatoid arthritis participated. In phase III clinical results, Rinvoq showed lower disease activity and improved clinical response rate compared to placebo, MTX or Humira(Adalimumab) group when used alone or in combination with a conventional synthetic antirheumatic drug (csDMARD). Seong-Hwan Park, a professor of rheumatology at Seoul St. Mary's Hospital, said, "Rinvoq shows a 20% higher remission rate compared to MTX at week 12 in SELECT-COMPARE, a phase III clinical trial administered in combination with MTX, which is a standard therapy. and he said that it will be used as a new treatment option that provides an opportunity to improve the quality of life.
- Policy
- Hanmi’s generic for Galvus is aiming for release next year
- by Lee, Tak-Sun Oct 23, 2020 09:44am
- Galvus by NovartisHanmi applied for item approval again three months after withdrawal of the DPP-4 inhibitory diabetes treatment 'Galvus' (Novartis, Vildagliptin) salt-modifying drug. Indications were not removed unlike existing products, and combination drugs were applied for permission. According to the MFDS and pharmaceutical industry on the 21st, Hanmi applied for item approval for a single drug for Vildagliptin HCl on the 29th of last month and a combination drug for Vildagliptin HCl /Metformin HCl on the 16th of this month. In January, Hanmi obtained an item license for Vildagliptin HCl. At the time, it was licensed to exclude two of the original drug uses. The company tried to obtain insurance benefits, but the Intellectual Property Trial and Appeal Board dismissed the request from Hanmi. Accordingly, as of July 6, Hanmi voluntarily withdrew the item. The item applied for permission this time contains the same six original uses unlike the previous case. It seems that it is now aiming for release on August 30th next year. Although it failed to split the indications, Hanmi and Ahn-Gook succeeded in invalidating Galvus' material patent duration extension period of 187 days. Accordingly, the product can be released on August 30 next year. However, in response to the Intellectual Property Trial and Appeal Board trial decision, Novartis has filed a lawsuit to cancel the trial decision to the Patent Court of Korea. The judgment of this lawsuit is scheduled for the 29th this month. It will be difficult to launch in August next year if the court takes the side of Novartis, then, it will be available only in March 2022, a year later. Hanmi applied for permission for the Metformin combination drugs at this time. Currently, Hanmi is the only generic company that has applied for a combination drug. Although it failed to launch this year, it can dominate the market with Ahn-Gook even if it is released next year. However, Ahn-Gook did not apply for a combination drug. It is analyzed that if Hanmi introduces a single drug and a combination drug at the same time, it will be more advantageous in the competition for market share of generic companies. According to UBIST in the first half of this year, the outpatient prescription sales of the original, Galvus and the combination drug, Galvusmet were ₩4 billion and ₩17.9 billion, four times larger in the combination drug market.
- Policy
- Saxenda must be prescribed thru outpatient Rx
- by Lee, Jeong-Hwan Oct 23, 2020 09:44am
- The MFDS stated that the principle is to issue outpatient Rx by applying the principle of separation of prescribing and dispensing drugs for self-injectable medicines such as obesity drug, Saxenda. Unless a doctor directly injects, according to the purpose of separation of prescribing and dispensing drugs, medical institutions such as hospitals and clinics should not directly prescribe or dispense self-injection drugs, but rather must dispense them at a pharmacy. On the 20th, the MFDS unveiled an agreement with the MOHW regarding self-injectable medicines in a written inquiry by Nam In-soon, a member of Democratic Party of Korea. She inquired about the need for safety management and prevention of drug abuse for self-injectable medicines. It was pointed out that self-injectable medicines should be reinforced during the national audit last year that the safe use measures for patients should be strengthened due to side effects such as bleeding, infection, and pain. In particular, she asked about the results of consulting the MFDS’ Central Pharmaceutical Affairs Review Committee in January this year to support measures to support the safe use of self-injectable medicines and the contents of consultations with the MOHW regarding the mandatory outpatient Rx. She clarified that self-injectable medicines is subject to separation of prescribing and dispensing drugs, and urged that the outpatient Rx be made mandatory and consulted with the MOHW so that the public can use it safely. The MFDS stated that based on the discussion of the MOHW, self-injectable medicines should be prescribed through outpatient Rx, unless the doctor injects directly. She said that she would discuss the details of outpatient Rx with the MOHW. The MFDS said, "To support the safe use of self-injectable medicines, we have created patient-participated information and planned patient education with experts." Saxenda has improved the packaging unit from the current 5 packaging to unit packaging." She added, “I confirmed the position of the MOHW that Issuing outpatient Rx for self-injectable medicines is a principle unless the doctor injects directly.” And she also said that outpatient Rx for self-injectable medicines is a task under the jurisdiction of the MOHW, and I will discuss the details in the future."
- Policy
- NA audit talks about pre-listing coverage on anticancer
- by Lee, Hye-Kyung Oct 23, 2020 09:44am
- At the National Assembly annual audit, a healthcare provider suggested the ‘pre-listing reimbursement and post-evaluation’ should be implemented and ‘incremental cost-effectiveness ratio (ICER) threshold’ should be adjusted to practically improve access to new drugs. Professor Kang Jin-hyoung at the Catholic University of Korea Seoul St. Mary’s Hospital, treating cancer patients at the clinical treatment scene, elaborated about the patients struggling to receive treatment due the delayed new drug reimbursement listing. However, the insurer, or the National Health Insurance Service (NHIS) and Health Insurance Review and Assessment Service (HIRA) expressed a reserved view on the suggestion. At the NHIS-HIRA National Assembly annual audit session on Oct. 20, Professor Kang Jin-hyoung was summoned as a witness and stated, “A novel anticancer treatment takes a long time to receive NHI reimbursement even after getting approved for the market by the Ministry of Food and Drug Safety (MFDS),” and “Patients are in immense pain as an immunotherapy for lung cancer could not pass HIRA for three years.” Regardless of how greatly effective a new drug is, it is not easy for the patients to actually use those drugs without the reimbursement. Professor Kang explained, “MOHW and HIRA say the anticancer treatment listing takes 350 days, but it excludes the time for requesting and submitting supplementary evidence. The time should be shortened to within 180 days for the patients and healthcare providers to actually feel the improvement.” The professor also noted although the risk sharing agreement system (RSA) introduced in 2014 contributed in speeding up the new drug listing procedure initially, the effect of RSA implementation on shortening the time has been insignificant due to expensive anticancer treatment entering the market. The professor stressed, “The social controversy is that most of immunotherapies can hardly get to RSA signing. After RSA was implanted, a half of anticancer treatments were listed through RSA, but the actual effect of shortening the listing period was weak,” and “The new drug listing speed has slowed down due to scarce review meetings amid COVID-19. If RSA were the only supplementary boost for the positive listing system, we need to pursue new options from now on.” Professor Kang recommended the following agenda to improve the new drug accessibility; providing pre-listing reimbursement and post-evaluation option, adjusting ICER threshold, and seeking means to secure additional source of NHI income to enhance public-private access. Regarding the ICER threshold for severe and rare disease treatments, the professor noted the threshold should be flexibly adjusted in a ‘bracket’ range, instead of basing it on GDP per capita. An independent Lawmaker Lee Yongho, who summoned Professor Kang, commented that “The patients would be desperate to access those new drugs,” and “Only controlling the NHI finance would not grant a solution. We need a balanced approach.” NHIS President Kim Yong-ik (left) and HIRA President Kim Sun-min (Source: National Assembly Correspondent Organization) Instead of clearly giving their opinion, however, NHIS President Kim Yong-Ik and HIRA President Kim Sun-min both claimed implementing a new system should be approached, carefully.. President Kim stated, “We can only be cautious when listing a new drug. Negotiating with a pharmaceutical company from a disadvantageous position can put NHIS and the government at risk when setting the drug pricing. And higher drug price can then put the patients in a worse situation. This is why the problem is difficult to solve.” On introducing the pre-listing reimbursement and post-evaluation, President Kim said, “We would review the suggestion, but we would not make any hasty decision as with have imminent issues regarding drug pricing and NHI finance.” HIRA President Kim Sun-min also said the accessibility issue is regrettable from the point of patients, but the suggested agenda would be difficult to execute without a social consensus. President Kim explained, “ICER threshold has to be effective when adding more cost. Recently listed anticancer treatments require cost of over 1 billion won to extend life expectancy by average one year,” so “We need to consider other patients and pursue the social consensus through thorough discussions.” “Although we would further make efforts to expand access to new drugs for severe and rare disease patients, we are already providing pharmacoeconomic evaluation exemption system and pricing negotiation exemption system,” nevertheless, “We would continue to improve the access,” said President Kim. After hearing from Lawmaker Lee Yongho’s witness, People Power Party Lawmaker Lee Jongseong spoke to President Kim Yong-ik, “You sounded negative about providing support to access the novel immunotherapy, but the administration promised, with the Moon Care, that no one would be neglected from accessing treatments. The government needs more forward-looking review. It should consider making a cancer fund and other options.” President Kim then answered, “We are absolutely not negative about expanding access to new drugs. Surely the alternative options should be considered, but the previous answer was concerned more of the pricing negotiation.”
- Policy
- Patients taking more than 10 drugs exceeded 2 million
- by Lee, Jeong-Hwan Oct 22, 2020 06:45am
- The number of multi-drug-drug patients who took more than 10 drugs at once exceeded 2 million last year. Korea ranks the highest among seven OECD countries that submitted statistics on multi-drug consumption, and the situation is serious. On the 20th, In Jae-keun, a member of Democratic Party of Korea, analyzed the national control data submitted by the NHIS and made this announcement. When taking multi-drugs, there is a high risk of drug effects or side effects due to drug interactions. According to a study by the NHIS, if older people 65 years of age or older take 5 or more drugs, they increase their risk of hospitalization by 18% and death by 25% compared to taking 1 to 4 drugs. The reality of taking multi-drug drugs in Korea is at a serious level. Last year, the OECD published the percentage of 75-year-old patients (as of 2017) who chronically take five or more drugs for 90 days or more, and Korea was the highest among the seven countries that submitted statistics. The proportion of Korea was 68.1%, and the average of 7 countries was 48.3%. The multi-drug prescription rate in Korea is increasing every year from 3.3% in 2016 to 3.5% in 2017, 3.8% in 2018, and 4.2% in 2019. The higher the age, the higher the multi-drug prescription rate was, and as of 2019, the multi-drug prescription rate of the 75-year-old or older population reached 23.6%. The multi-drug prescription rate is the number of people who took 10 or more drugs for 60 days or more in the year divided by the number of people who received the prescription at least once in the year. The number of patients taking multi-drugs is also increasing. The number of multi-drugs users from 1,548,000 in 2016 increased every year to 2,012,000 last year. During the same period, the multi-drug taking rate also increased from 3.0% to 3.8%. Looking at multi-drugs users by age, as of 2019, 841,000 people aged 75 and over (22.4% dose rate), 600,000 people aged 65-75 (12.2% dose rate), and 401,000 people aged 55-65 (4.8%), 127,000 people aged 45 to 55 (1.4%), and 43,000 people under the age of 45 (0.2%). There was also a difference in the status of multi-drugs users by income. As of last year, the first quintile was the highest at 5.8%, followed by the 10th (4.2%) and the ninth (3.7%). The 2nd to 8th quartiles showed similar figures around 3.0%. This means that those with higher income levels than those with intermediate income levels and those with the lowest income level than those with higher income levels had a higher rate of taking multi-drugs. In particular, in the case of medical benefits, the multi-drugs use rate reached 19.4%, requiring special attention. She said, "The current state of multi-drugs use in Korea is another aspect of an excellent pharmaceutical system," and pointed out that "the government needs attention for improvement." She stressed that it is urgent to manage multi-drug products for the elderly and low-income groups, including medical care recipients, to promote it as an official project.
- Policy
- 9 non-reimbursement vaccines could save ₩40 billion
- by Lee, Jeong-Hwan Oct 22, 2020 06:43am
- It was argued that expanding the National Immunization Program (NIP) and including non-reimmbursement vaccines in the scope of health insurance coverage would be effective in reducing socioeconomic losses and strengthening health insurance finances. It is pointed out that it is possible to reduce the socio-economic cost of ₩39.9 billion by ₩3.65 billion for adult vaccination against nine diseases such as pneumonia and mumps. On the 20th, Jung Choun-sook, a member of Democratic Party of Korea, announced this through the Korea Disease Control and Prevention Agency and the HIRA submission data. According to data from the Centers for Disease Control and Prevention (CDC) submitted by the Korea Disease Control and Prevention Agency, the cost of vaccines compared to hospitalization costs was only 0.02% to 3.78%. Specifically, the cost of hospitalization for tetanus was $102,524, while the cost of the vaccine (based on children) was only $16.34 to $61.65. Hospitalization costs for pneumococcal disease ranged from $3,798 to $25,848. Looking at the treatment status of these nine diseases over the last three years, the number of pneumococcal disease patients from 2018 to June 2020 was 10,588, and the total amount of medical care benefit expenses was about ₩18.945 billion. The number of patients for mumps was 33,464, the cost of medical care benefits was about ₩2,964 million, the number of patients for chickenpox was 194,700, and the cost of medical care benefits was about ₩14,87 billion. On the other hand, even though the cost of the vaccine is not covered, the cost of the vaccine will be ₩61,501/person at a hospital for pneumococcal disease, and if all 10,588 patients are vaccinated, the cost of the vaccine will be ₩651 million. For mumps, the vaccine cost is ₩11,390/person, and if all 33,464 patients are vaccinated, the vaccine cost will be ₩381 million. Chickenpox amounts to ₩13,020, and ₩2,535 billion, if 194,700 people are vaccinated. It is much more economical if the disease is prevented by vaccination. She believes that vaccination is the most effective public health intervention tool in terms of cost/benefit, and if NIP is expanded through national health insurance reimbursement, and that it will ultimately help finance health insurance by reducing socioeconomic losses and reducing medical costs. As of this year, the nationally supported NIP include 'Children's NIP' for children under 12 years of age (17 types of vaccines eligible for free vaccination such as tuberculosis, hepatitis B, diphtheria, tetanus, whooping cough, etc.), 'Healthy Women's First Step Clinic Project' targeting female adolescents aged 12 years, 'Influenza NIP' targeting seniors 65 years of age or older, 6 months to 12 years old, and pregnant women, and 'Elderly pneumococcal disease NIP' targeting seniors 65 years of age or older. 정춘숙 의원은 "예방접종은 비용 대비 편익 측면에서 가장 효과적인 공중 보건 중재 수단"이라며 "국민건강보험 급여화를 통해 예방접종사업을 확대하면, 사회경제적 손실을 줄이고 의료비용 절감을 통해 궁극적으로 건강보험 재정에 큰 도움을 줄 수 있다"고 강조했다. 한편 예방접종 비용을 국가가 지원하는 국가예방접종 사업은 올해를 기준으로 만 12세 이하 어린이를 대상으로 한 '어린이 국가예방접종 지원사업'(결핵, B형간염, 디프테리아, 파상풍, 백일해 등 무료접종 대상 백신 17종), 만 12세 여성 청소년을 대상으로 한 '건강여성 첫걸음 클리닉사업', 만 65세 이상 어르신, 생후 6개월~12세 어린이, 임신부를 대상으로 한 '인플루엔자 국가예방접종 지원 사업', 만 65세 이상 어르신을 대상으로 한 '어르신 폐렴구균 예방접종사업' 등이 있다.
- Company
- Kisqali to be listed November starting three-way competition
- by Eo, Yun-Ho Oct 22, 2020 06:32am
- The cyclin-dependent kinase 4/6 (CDK4/6) inhibitor market is expanded to a three-way competition. A pharmaceutical industry source reported, Novartis’ hormone receptor-positive (HR+) and human epidermal growth factor receptor 2-negative (HER2-) breast cancer treatment Kisqali (ribociclib) has concluded the pricing negotiation with National Health Insurance Service (NHIS). The drug is expected to get listed for reimbursement through a refund type risk sharing agreement (RSA). As a third CDK4/6 inhibitor, Kisqali entered the market the last but its position is not completely negative. The main competition in the market centers the Faslodex (fulvestrant) combination therapy, in which Pfizer’s Ibrance (palbociclib) and Lilly’s Verzenio (abemaciclib) are already in the game with five months gap apart from the point of reimbursement listing. Ibrance and Verzenio were approved in South Korea in August 2016 and May last year, respectively. But considering Kisqali was approved last year October, its gap of reimbursement listing with those two drugs was relatively short. Moreover, Kisqali’s reimbursement standard is looser than the first two drugs. The drug can be prescribed not only to postmenopausal patients who have never had an oophorectomy, but also to premenopausal patients, which would make Kisqali a favorable option. Professor Im Seock-ah of Hemato Oncology Department at Seoul National University Hospital explained, “The MONALEESA-7 study was mainly proposed and led by an Asian researcher, and had 30 percent of Asian patients as registered sample. These findings reflect how Asian region still has a great need for a new treatment option in premenopausal women with breast cancer”. The Phase 3 MONALEESA-7 clinical trial evaluated Kisqali combined with endocrine therapy (either an aromatase inhibitor or ovarian function suppression) as a first-line treatment in pre and perimenopausal women with HR+/HER2- advanced or metastatic breast cancer, and confirmed the drug’s effect of significantly extending patient’s overall survival (OS). Specifically, the Kisqali combination group demonstrated median progression-free survival (mPFS) of 23.8 months, whereas endocrine therapy only group had 13 months. In a subset analysis on Asian patients only, the Kisqali combination group’s mPFS was at 24.7 months, which was about 14 months longer than the endocrine therapy only group’s. Also in Phase 3 MONALEESA-3 study, Kisqali confirmed its effect of extending the OS in pre and postmenopausal women. At the point of 42 months, the OS in Kisqali combination group was at 58 percent, and fulvestrant only group was at 46 percent.
- Policy
- Eplerenone was first approved in Korea
- by Lee, Tak-Sun Oct 22, 2020 06:31am
- Pfizer’s Inspra (Eplerenone) The drug for hypertension and chronic renal failure, which was not introduced in Korea, was first approved by a small and medium-sized pharmaceutical company in Korea. The MFDS approved a drug for data-based re-evaluation of two doses of Theragen Etex's Eplerenone formulation on the 21st. Eplerenone is generic for Inspra, which was approved by the US FDA for hypertension treatment in 2002. It was approved as a treatment for congestive heart failure in 2003. Inspra is a drug developed by Pharmacia before the acquisition of Pfizer. It is known as an Aldosterone antagonist, such as Spironolactone, as a potassium-sparing diuretic agent. Pfizer did not introduce Inspra instead of launching 'Aldactone film coated tab' with spironolactone component in Korea. It is known that Inspra did not achieve sales performance as expected due to Spironolactone formulation overseas. Pfizer did not introduce Inspra while launching 'Aldactone film coated tab' containing Spironolactone in Korea. It is known that Inspra failed to achieve as much as expected due to the Spironolactone formulation overseas. Pfizer has its best-selling drug, Norvasc which is a calcium channel blocker that dilates blood vessels and improves blood flow. Pfizer acquired Pharmacia in 2002 and secured famous pipelines such as Celebrex. Since it was not introduced in Korea, there are no licenses or patents on the Orange book of the MFDS. Therefore, there is no difficulty for generics to enter the market because the original has not been introduced in Korea. Theragen Etex also recognized this and belatedly started to approve the item. Eplerenone from Theragen Etex can be used for hypertension and chronic heart failure (when receiving basic treatments such as angiotensin converting enzyme inhibitors or angiotensin II receptor antagonists, β blockers, and diuretics). The amount of outpatient prescriptions for Aldactone, was ₩2.8 billion last year. Although the market size of drugs for hypertension and chronic heart failure is large, new drug competition is fierce, so the sales volume of Eplerenone, which was introduced lately in Korea, will only be known after time.
