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- 2026-04-09 06:29:31
- Company
- Zavicefta nears final negotiations for reimb in KOR
- by Eo, Yun-Ho Oct 31, 2023 05:35am
- Whether the next-generation antibiotic ‘Zavicefta’ will be successfully listed for reimbursement is gaining attention. Under the Ministry of Health and Welfare’s order to proceed to drug pricing negotiations, Pfizer Korea is soon set to begin pricing discussions for ‘Zavicefta’ (ceftazidime-avibactam). The drug passed the Health Insurance Review and Assessment Service’s Drug Reimbursement Evaluation Committee review last September. However, unlike other drugs that almost immediately started negotiations, the company wasn’t able to start drug pricing negotiations for the drug right away. With the negotiations soon to begin, it remains to be seen whether a new antibiotic drug will be listed in an area where no other drug than MSD Korea's Zerbaxa (ceftolozane-tazobactam) has brought results. Zavicefta was developed to address the urgent need for new antibiotics in severe infections that cause serious problems such as multidrug-resistant pseudomonas aeruginosa or carbapenem-resistant gram-negative Enterobacteriaceae and extended-spectrum-lactamase (ESBL) producing intestinal bacteria. Zavicefta is used to treat adult patients suffering from complicated intra-abdominal infections (cIAI); complicated urinary tract infections (cUTI), including pyelonephritis; hospital-acquired pneumonia (HAP); and the treatment of aerobic Gram-negative infections in adult patients who have limited treatment options. Zavicefta was originally developed by AstraZeneca. In 2016, Pfizer acquired the drug while acquiring AstraZeneca’s antibiotic business. Securing a new treatment alternative for carbapenem is a global health issue publicized by the WHO. Multidrug-resistant Gram-negative bacteria are increasing worldwide and have recently become a serious problem in healthcare-associated infections. This is why the WHO had designated carbapenem-resistant Pseudomonas aeruginosa as a Priority 1: Critical pathogen that requires research and development of new antibiotics. Korea’s pseudomonas aeruginosa resistance rate to carbapenems is 30.6%, the second highest among the surveyed countries after Greece. Also, the ESBL (extended-spectrum beta-lactamases)-producing Enterobacteriaceae are also showing resistance to cephalosporin antibiotics that are effective against a wide range of gram-negative bacteria. Currently, new antibiotics available in Korea include MSD’s anti-infective Zerbaxa (ceftolozane-tazobactam) and Pfizer’s antifungal ‘Cresemba (isavuconazonium).’
- Company
- Jyseleca to be launched in earnest next month
- by Eo, Yun-Ho Oct 30, 2023 05:30am
- A fifth entrant has joined the competition in the JAK inhibitor market. The Japanese pharmaceutical company, Eisai Korea’s ‘Jyseleca’ will be listed for reimbursement starting next month (November). Its first reimbursed indication is rheumatoid arthritis and moderate to severe active rheumatoid arthritis. Patients eligible for reimbursement are those aged 65 or older who do not respond adequately to or are intolerant to existing treatments or those who show inadequate response or are intolerant to TNF-α inhibitors. Jyseleca received a conditional reimbursement decision for rheumatoid arthritis and ulcerative colitis indications from HIRA’s Drug Reimbursement Evaluation Committee in July. At the time, DREC judged that reimbursement was adequate if the company accepted a price less than the evaluated amount. As such, Eisai Korea appears to have accepted a price below the assessed value. The company skipped negotiations on the insurance price ceiling that requires negotiation with the National Health Insurance Service by accepting a price that is below 90% of the weighted average price of its alternative, thereby jumping into the JAK inhibitor drug competition. JAK inhibitors currently available in Korea are Xeljanz (tofacitinib), Olumiant (baricitinib), and Rinvoq (upadacitinib).’ These drugs have received a lot of attention upon introduction as the first oral drug options to demonstrate equivalence to anti-TNF agents in the field of autoimmune diseases. These drugs have been steadily expanding their indications and reimbursement standards since their launch. Xeljanz, which was the first to be developed, secured additional indications for ulcerative colitis and psoriatic arthritis last year, and later entrants, including Rinvoq, have also been expanding their prescriptions to autoimmune diseases such as atopic dermatitis, Crohn's disease, and ankylosing spondylitis. Meanwhile, Jyseleca (filgotinib) is an adenosine triphosphate (ATP) a competitive and reversible inhibitor that selectively inhibits JAK1. JAK1 is a substance that transmits inflammatory cytokine signals and is considered a major treatment target for rheumatoid arthritis. Some of the recent treatments inhibit JAK2 or JAK3 by indication, but there is some opinion that both mechanisms are involved in immune cell proliferation and homeostasis regulation, and may cause adverse reactions. The drug's efficacy was demonstrated through Phase III trials, including FINCH1, FINCH2, and FINCH3. In the FINCH1 study, the drug improved arthritis symptoms by more than 20% at 12 weeks when administered to patients with moderate-to-severe active RA (rheumatoid arthritis) despite continued methotrexate (MTX) treatment.
- Company
- Heart failure drug Entresto continues to grow rapidly
- by Kim, Jin-Gu Oct 30, 2023 05:30am
- Entresto Novartis' heart failure treatment Entresto continues to grow rapidly thanks to increased benefits. Although it has been six years since it was launched in Korea, prescriptions are increasing by more than 30% every quarter compared to last year. However, Entresto faces challenges from several successor products. Recently, Verquvo, a new heart failure drug with a new mechanism, was released, and SGLT-2 inhibitor diabetes treatments are expanding their indications to the heart failure area. Additionally, generic companies are actively challenging Entresto's patent evasion and invalidation. Quarterly prescription volume approaching 15 billion won, still growing rapidly 6 years after launch. According to UBIST, a pharmaceutical market research firm, on the 28th, Entresto's out-of-hospital prescriptions in the third quarter were KRW 14.8 billion. It increased by 36% in one year compared to 10.9 billion won in the third quarter of last year. Six years have passed since its release in the fourth quarter of 2017, but it is still showing high growth. It grew by more than 30% every quarter compared to the same period last year. It exceeded 5 billion won in the first quarter of 2020, and expanded to more than 10 billion won in the second quarter of 2022. If the current trend continues, it is expected to exceed 15 billion won in the fourth quarter of this year. The analysis is that there was no suitable treatment for heart failure before the launch of Entresto and that the company was able to quickly increase prescriptions by enjoying a monopoly position without competing drugs after the product launch. The steady expansion of the salary range is also considered a factor in maintaining high growth. Entresto's coverage has been expanded to 'first-line treatment of HFrEF with a left ventricular ejection fraction of 40% or less' since July of this year. Domestic chronic heart failure patients can now use Entresto from the first treatment, even if they do not take a stable dose for more than 4 weeks in combination with standard treatment such as ACE inhibitors or ARBs. In March last year, coverage was expanded to primary treatment for hospitalized patients with acute decompensated heart failure. For patients who were hemodynamically stabilized after hospitalization for acute decompensated heart failure, benefits were recognized when administered Entresto even if ACE inhibitors or ARB drugs were not administered. Competition is expected with follow-up new drugs, SGLT-2 diabetes drugs, generic drugs, etc. However, opinions differ on how long this growth trend will continue in the future. This is because we face challenges from a variety of competing products. First of all, Verquvo, another heart failure treatment from Bayer, was released last September with insurance coverage. It is expected that full-fledged prescriptions will be made once the drug passes the Pharmacist Committee (DC) at major general hospitals. Verquvo is a treatment for chronic heart failure with a new mechanism. It is a mechanism that promotes the synthesis of cyclic guanoic acid monophosphate (cGMP) within cells. Unlike existing ACE I or β-blockers, which suppress the activation of the neuro-hormonal system due to myocardial and vascular dysfunction, it improves myocardial and vascular function by directly stimulating sGC to promote cGMP synthesis. In the pharmaceutical industry, as it is a treatment option with a new mechanism that has emerged for the first time in a long time since Entresto, it is predicted that prescriptions will rapidly expand in clinical settings in the future. SGLT-2 inhibitor-type diabetes treatments such as Forxiga and Jardiance are also expected to pose a challenge. Both drugs recently received approval for expanded indications for heart failure. Subsequently, an application was made to expand benefits based on efficacy and effectiveness. Forxiga was applied for reimbursement for heart failure with reduced cardiac output and chronic renal failure, and Jardiance was applied for heart failure with reduced cardiac output and heart failure with preserved left ventricular ejection fraction. In the case of Forxiga, as it has also obtained indications for heart failure with preserved left ventricular ejection fraction and reduced mildness, it is expected that applications for reimbursement in this area will continue in the future. Last year, related academic societies in the United States and Korea successively recommended Forxiga and Jardiance as treatments for heart failure. The American College of Cardiology (ACC), American Heart Association (AHA), and Heart Failure Society of America (HFSA) jointly recommended SGLT-2 inhibitors, such as Farxiga, as a treatment for mild or preserved heart failure in the 2022 revised heart failure guidelines (recommendation level) 2a). The Korean Society of Heart Failure also recommended SGLT-2 inhibitors in patients with preserved ejection fraction, regardless of the presence or absence of diabetes (recommendation grade 1). Entresto is also facing patent challenges from generics. (From left) Product photos of Verquvo, a new heart failure drug, and Forxiga and Jardiance, SGLT-2 inhibitor diabetes drugs. All three products are evaluated as competitors to Entresto Domestic pharmaceutical companies, including Hanmi Pharmaceutical, Chong Kun Dang, Samjin Pharmaceutical, Hana Pharmaceutical, and Angook Pharmaceutical, are pursuing lawsuits to avoid the Entresto patent. Last year, Hanmi Pharmaceutical was the first to succeed in capturing all five Entresto-related patents. Afterward, 9 additional companies won. Novartis disagreed with the first trial result and appealed. We are currently awaiting the patent court's ruling. The Patent Court announced November 9 as the date for the second trial of the Entresto crystalline patent lawsuit. The verdict was originally scheduled to be handed down in September but was postponed for about two months. In the case of two pharmaceutical patents expiring in 2029, the first trial victory for generic companies has been confirmed. If the patent challengers win in the second trial and succeed in neutralizing the remaining patents, the launch of the generic Entresto is expected to come closer.
- Policy
- Dupixent receives the green light for reimb extensions
- by Lee, Tak-Sun Oct 30, 2023 05:30am
- The insurance authorities showed a positive stance on expanding coverage of Dupixent (dupilumab, Sanofi), which is available for patients with severe atopic dermatitis from 6 years of age, to critically ill infants and toddlers from 6 months to 5 years of age. Depending on the cost-effective review results, the reimbursement process may gain momentum in the future. In addition, it appears that the authorities are also reviewing reimbursing the drug for another indication, asthma. The Health Insurance Review and Assessment Service recently revealed so in response to a written inquiry they received at the NA audit. Last April, Sanofi applied HIRA to expand reimbursement so that infants and young children with symptomatic atopic dermatitis from 6 months to 5 years of age can also receive reimbursement for the drug.”. Dupixent obtained the relevant indication from the Ministry of Food and Drug Safety on November 3 last year. The indication was approved based on the results of a Phase III clinical trial (LIBERTY AD PRESCHOOL) that was conducted on atopic dermatitis patients aged 6 months to 5 years of age, which confirmed a significant improvement in AD lesions compared to the placebo group. HIRA subsequently held an expert advisory meeting and reported the review plan to the Ministry of Health and Welfare to secure the feasibility of expanding Duppixent’s reimbursement to infants and toddlers. A full-scale cost-effectiveness evaluation will be conducted accordingly. Regarding the application of reimbursement for the asthma indication, the agenda is also expected to enter the cost-effectiveness evaluation stage soon. It is said that the reimbursement standards were set after two expert advisory meetings held to prepare the reimbursement standards. Dupixent is indicated for severe eosinophilic asthma and oral corticosteroid-dependent severe asthma in adults (aged 18 and older) and adolescents (aged 12 to 17). At the expert advisory committee that took place last July, the members decided that the reimbursement standards should be set, but undergo additional expert advice on the unification of terminology and detailed standards with other drugs in the process of being listed for reimbursement for the same indication. Additional expert advice and opinion collection were conducted thereafter. Based on this, if a reimbursement standard plan is prepared and reported to the Ministry of Health and Welfare, a cost-effectiveness evaluation for the indication will also begin, similar to the case of AD in infants and toddlers. As Cinqair Inj and Nucala Inj, which are biological asthma drugs, have recently succeeded in being reimbursed, the possibility of Dupixent's successful reimbursement expansion has also been increasing. Of course, it takes a considerable amount of time to evaluate cost-effectiveness and it is not easy to pass, so it is currently impossible to predict when the reimbursement expansion will take place. Nevertheless, as the feasibility of expanding the salary standard has been recognized, it is expected that the reimbursement process can accelerate if pharmaceutical companies are willing to present appropriate cost-sharing plans. In addition to the reimbursement extension, Dupixent is also in the process of renewing its risk-sharing contract. After the first round of RSA renewal negotiations broke down, it seems highly likely that a contract renewal will be agreed upon in the second round of negotiations. Attention is being paid to whether Dupixent's Sanofi will be able to kill two birds with one stone, by expanding reimbursement and renewing the risk-sharing agreement, remains to be seen. Based on IQVIA, Dupixent posted sales of KRW 105.2 billion in 2022. As claims are expected to increase further this year due to reimbursement extension to children and adolescents, there is a possibility that the pharmaceutical company's share of the burden will increase with the renewal of the risk-sharing system.
- Company
- Nic Horridge resigns as CEO of Roche Korea
- by Eo, Yun-Ho Oct 30, 2023 05:29am
- CEO Nic Horridge According to related industries, CEO Nic Horridge will step down as CEO of Roche's Korean subsidiary at the end of this month and become CEO of the Australian subsidiary. CEO Nic Horridge was appointed as CEO of Roche Korea in October 2018 and led the company for approximately five years. During his tenure, he achieved the expansion of primary lung cancer coverage of the immunotherapy drug Tecentriq, as well as the listing of new items such as spinal muscular atrophy treatment Evrysdi, eye disease treatment Vabysmo, and cancer-regarding cancer drug Rozlytrek. In addition, he promoted Agile Transformation, which was carried out at the headquarters level to quickly and flexibly make the organization's work methods and operating model. Unlike general pharmaceutical company employees who are responsible for each product, employees are responsible for diseases, or specific indications. However, in the process, quite a few issues of personnel adjustment and departure occurred. Meanwhile, CEO Nic Horridge has served as the leader of the marketing division in several countries around the world, including the headquarters, since joining Roche's New Zealand branch in 2005, and served as Roche's Vietnam branch manager from May 2016 until recently. Before joining Roche, he had extensive business experience in sales and marketing for 3M Healthcare and received a bachelor's degree in cell biology and a doctorate in molecular biology from the University of Canterbury in New Zealand.
- Policy
- NA criticizes HIRA's low prior approval of specific drug
- by Lee, Tak-Sun Oct 30, 2023 05:29am
- In response to the criticism that the prior review approval rate of certain drugs is low, the Health Insurance Review and Assessment Service said that the low rate is due to a lack of understanding of the reimbursement standards and that it will maintain the current standards. The response was made regarding the low approval rate of Soliris for aHUS (atypical hemolytic uremic syndrome) disease. On the 18th, Rep. Sun-Woo Kang of the Democratic Party of Korea made a written inquiry about the low prior approval rate of certain drugs used for aHUS during the NA audit of the Health Insurance Review and Assessment Service. aHUS is a severe and rare hereditary disease in which 79% of patients die or require dialysis within 3 years of onset and suffer permanent renal failure. Also, patents with aHUS experience 'thrombotic microangiopathies (TMA)' (a condition in which blood clots and inflammation damage small blood vessels throughout the body), and major organs such as the kidneys, heart, and brain become damaged, bringing about various complications such as acute renal failure, heart failure, and stroke. In acute cases, the disease can tear internal organs within 1 week, especially the walls of the kidneys, which severe cases lead to death. The prior approval system was implemented in 1992 as a system that allows a prior review subcommittee, which consists of several experts, to decide whether or not to allow reimbursement for each case before treatment to allow patients in dire need of treatment with high-priced rare disease treatments. The system has been applied to pharmaceuticals since 2007. This is not the first time Soliris' low approval rate for aHUS has been raised as an issue. According to the data presented by Yong Kyun Won, Professor of Radiation Oncology at Soonchunhyang Univ. Cheonan Hospital, Soliris’s prior approval rate for aHUS was only 21.6%. None of the 6 new applications filed in July that were disclosed by the HIRA passed expert review. This is why experts in the field have expressed concerns saying, "If the prior review approval rate is low, the prescribing doctor may give up use of the drug in advance, impeding patient access to treatment." However, HIRA has been arguing that the low approval rate is not a concern, rather, it is due to a lack of understanding of the reimbursement standards. In a response to Rep Kang’s written inquiry, HIRA stated, "The approval rate for aHUS is low because medical institutions have been filing many applications to receive help from experts in the prior review subcommittee on determining the reimbursement adequacy of their patients or apply with a lack of knowledge about the reimbursement standards, rather than clearly determining the eligibility and exclusion criteria themselves based on each patient’s medical records. In addition, regarding the criticism about the strict reimbursement standards, HIRA answered, “A reimbursement t expansion request has been filed recently, asking for ‘'ease of the TMA requirements in the aHUS salary standards.’” After discussing the request at an advisory meeting, including experts from related societies such as the Korean Society of Nephrology, they concluded that the current standards should be maintained, as no new clinical evidence has been generated to warrant a change, and the prior review subcommittee has been reviewing the situation of each patient in consideration of the comprehensive situation of each patient for cases that require medical judgment.” Despite so, concerns have continued to rise in the field. In a survey conducted on relevant societies in the ‘Current Status and Improvement Plan for Medical Benefit Prior Approval System (2022)’ that was conducted by HIRA, the relevant societies said that the criteria for selecting target drugs for the prior review system have not been specified, and the varying composition of the expert committee members that discuss each reimbursement can bring different results. Related academic societies said, “Although the prior review application process in itself is complicated, there is a lack of sufficient explanation regarding the progress or reasons for disapproval. Patients miss out on the appropriate treatment period due to the prior review meeting schedule, which is held once or twice a month. Therefore, flexible operation may be necessary to review cases that arise by case." In addition to Rep Kang, Rep Chounsook Jung from the same party had also raised the issue of the prior review approval rate of a specific drug. Jung made a written inquiry to the health authorities regarding the cases of disapproval of Spinraza, which is used to treat spinal muscular atrophy (SMA), and the need for their improvement. Spinraza’s scope of administration has been expanded starting in October. Its subjects have been expanded from those under the age of 3 to those under the age of 18 who show onset of symptoms. Rep. Jung pointed out that measures are needed for patients who were not approved before the change of the standards. Regarding this, HIRA said, "Patients who were previously disapproved because they did not meet the existing age requirements may be able to receive reimbursement if they meet all the reimbursement requirements after evaluation through the prial approval process in line with to the expansion of the age requirement. However, patients who were disapproved while receiving other drugs after review would need to consider that their decision was made based on the expert opinion that ‘after a close and careful review of the medical records (progress record, test results, video, etc.), the members of the ‘prior review subcommittee’ that consist of many experts made the professional medical judgment that ‘it cannot be determined whether the motor function can be maintained or improved with administration of the medication.” HIRA added, “We also have a relief procedure that allows patients and caregivers to file an appeal to the prior review results, and committee members rediscuss the rejected cases based on the submitted explanatory material. If the patient or institution has an objection to the appealed results, they may seek relief for the patient’s rights through administrative adjudication by the Health Insurance Dispute Mediation Committee." HIRA added that 10 administrative adjudications have been filed, 8 of which were rejected, and 2 are under review.
- Policy
- New dug price reeval standards will be set within the year
- by Lee, Jeong-Hwan Oct 27, 2023 05:33am
- The Health Insurance Review and Assessment Service said, “We will prepare a final plan within this year” to an inquiry on the progress made on the reevaluation of off-patent drugs through a comparison of overseas drug prices. In particular, based on the established reevaluation standards, HIRA also expressed their intention to sequentially carry out reevaluations starting next year and reduce the prices of drugs listed at higher prices compared to overseas to secure the financial sustainability of Korea’s national health insurance. Such will were found in the response submitted to answer People Power Party Rep. Young-Hee Choi’s written inquiry during the NA audit on the 25th. Regarding the comparison of overseas drug prices, HIRA explained that it had improved the foreign drug price reference standard (foreign drug price conversion formula) through the operation of a working group with the pharmaceutical industry last year. HIRA is currently working with the Ministry of Health and Welfare to prepare a plan to compare and reevaluate overseas drug prices of listed drugs and announced that it will prepare a final plan within this year after gathering opinions through meetings with the pharmaceutical industry. HIRA said, “We plan to carry out the revaluations sequentially on an annual basis starting next year. We will secure the sustainability of health insurance finances by managing the expenditures spent on drugs listed at a higher price compared to foreign countries.”
- Company
- Nephoxil can be prescribed at general hospitals
- by Eo, Yun-Ho Oct 27, 2023 05:33am
- Nephoxil, a hyperphosphatemia treatment drug, is entering the prescription range of general hospitals. According to related industries, Kyowa Kirin Korea's Nepocsil has passed the Drug Committee of about 50 hospitals across the country, including Sinchon Severance Hospital. Nephoxil was developed as a new iron-based phosphorus binder with high solubility, and through clinical trials, it not only has a phosphorus control effect but also has an additional anemia correction effect, reducing the dosage of hematopoietic hormones and iron injections. In addition, the capsule formulation is evaluated to not only improve medication compliance but also contribute to the economical treatment of hyperphosphatemia patients among hemodialysis patients. Nephoxil was approved for improving hyperphosphatemia in chronic kidney disease patients receiving hemodialysis and was listed on the health insurance coverage list on July 1. It is imported and sold by Kyowa Kirin Korea, the Korean subsidiary of Japanese Kyowa Kirin, but it was developed by a Taiwanese pharmaceutical company, not Japan. This can be seen as a rare case where a Taiwanese new drug was imported domestically and even applied for reimbursement. In particular, this drug was not listed in the A7 reference country, but it was cheaper than alternative drugs and took only 1 year and 2 months from approval to reimbursement. Non-calcium drugs currently on the market include Sanofi Renvela, SK Chemicals Invela, and JW Pharmaceuticals Fosrenol. In particular, several generic Renvela drugs have recently come out and are competing with it.
- Policy
- Galvusmet generics released in all dosage forms in KOR
- by Lee, Tak-Sun Oct 27, 2023 05:33am
- Novartis Korea The second round of competitions is now on with the entry of Galvusmet generics. If the first round was held between generics before and after Galvusmet’s substance patent expiry, the second round this time expected this time is set to start with the release of Galvusmet generics that come in all dosage forms. According to the industry on the 26th, Daewoong Bio, Mothers Pharmaceutical, and Korea Hutex Pharmaceutical, led by the contracted CDMO Genuone Science, will launch all dosage forms of Galvusmet generics. Galvusmet is a combination of the DPP-4 inhibitor vildagliptin and metformin hydrochloride. Novartis Korea received approval for the drugs in 2008 in Korea. It had been offered in three doses, Galvusmet Tab 50/500mg, Galvusmet Tab 50/850mg, and Galvusmet Tab 50/1000mg. Five companies (United Pharma Korea, Shinpoong, Ahn-gook, Ahn-gook New Pharm, Samjin) had previously released a 50/500mg dosage of the same-ingredient generic. Only Hanmi Pharmaceutical’s Vildaglmet Tab and KyungBo Pharma’s Vildamet Tab offered all the dosage forms offered by Galvusmet, and were self-modified drugs. So this is the first time 50/850mg, and 50/1000mg same-ingredient generics are being released in Korea. Last year, Galvus (including single and combination drugs) posted outpatient prescription sales of KRW 14.5 billion (UBIST data). Among the amount, the original Galvus series posted KRW 32.4 billion in prescriptions, down 30% YoY due to the release of generics. Among the latecomers, Hanmi’s Vildagle series showed the highest performance of KRW 3.9 billion. The analysis is that the company succeeded in preoccupying the market by launching a variety of dosage options. The competition is expected to intensify further with the release of the generic versions in all dosages. In particular, these Galvus generics were released after the enforcement of patent avoidance and bioequivalence t sharing regulations 1 (consignee) + 3 (consignor) and therefore will have fewer competitors than Forxiga or Januvia, which will work in favor of the generic companies in terms of sales and marketing. Also, the fact that the market size for the combination drug Galvusmet is 5 times larger than that of its single-agent drug Galvus is also a factor that the generic companies are looking forward to. Last year, Galvus recorded outpatient prescriptions of KRW 5.4 billion, while Galvusmet recorded KRW 26.9 billion.
- Company
- Livtencity aims to enter the reimbursement market
- by Eo, Yun-Ho Oct 27, 2023 05:33am
- According to related industries, Takeda Pharmaceutical Korea's Livtencity submitted a benefit application in the third quarter of last year, has completed PE, and is currently submitting it to the HIRA Pharmaceutical Reimbursement Evaluation Committee. Accordingly, it remains to be seen whether an alternative treatment option can be developed for patients resistant to existing drugs. CMV is a type of herpes virus that infects more than 60% of adults worldwide at least once in their lives. It is a typical disease that occurs in patients who use immunosuppressants after hematopoietic stem cell (HSCT) transplantation. The risk is such that 30-70% of hematopoietic stem cell transplant patients experience CMV viremia. In hematopoietic stem cell transplant patients, CMV disease causes multi-organ diseases such as pneumonia, hepatitis, gastroenteritis, retinitis, and encephalitis, of which pneumonia has a mortality rate of up to 60%. Because CMV in immunocompromised patients is fatal, preemptive treatment is generally administered, mainly ganciclovir, valganciclovir, foscarnet, and cidofovir, and hospitalization is essential. Additionally, because these drugs have similar mechanisms if resistance to one drug develops, it is highly likely to not respond to other treatments. With the advent of Livtencity, there is hope for secondary treatment. Livtencity has almost no side effects compared to existing drugs and can provide an alternative in cases where resistance to these treatments develops. The antiviral activity of this drug, Livtencity, inhibits CMV proliferation and migration through a differentiated multi-modal mechanism of action that inhibits the protein kinase of the HCMV enzyme UL97. It not only inhibits DNA from coming out of cells but also inhibits DNA replication and virus encapsulation. Livtencity was approved by the US FDA as the first treatment for CMV-infected patients in November 2021 and was approved in Korea in December last year.
