- LOGIN
- MemberShip
- 2026-03-19 12:07:18
- Company
- Nexavar reimbursement cleared for severe HCC patients
- by Eo, Yun-Ho Jan 06, 2020 06:20am
- From this year, reimbursed prescription would be granted on liver cancer treatment Nexavar treating patient with severe liver dysfunction. According to the new pharmaceutical listing, reimbursement on Nexavar (sorafenib) would be provided for a patient, including pediatric patient, with advanced hepatocelluar carcinoma (HCC) who is unable to undergo local treatment like surgery or transarterial chemoemoblization (TACE), and qualifies condition of being classified as class A or B7 according to Child-Pugh scoring; in Stage III or more advanced; or classified as Grade 0 to 2 of ECOG Performance Status. Provided by the newly revised listing, treatment access to Nexavar has been expanded not only for patients with good liver condition graded by Child-Pugh scoring, but also for patients with HCC with severe liver dysfunction. The coverage expansion has been decided based on the safety profile confirmed in the GIDEON study incorporating HCC treatment guideline from home and abroad and numerous HCC patients classified in class B7 by Child-Pugh scoring. With 3,371 participants around the world with unresectable HCC, GIDEON study evaluated safety of sorafenib by treating the subgroup patients with 800 mg of sorafenib daily, reduced when necessary. The study found consistent safety profile in over 70 percent of the participants, specifically in Child-Pugh A patient group (61 percent) and Child-Pugh B7 patient group (11 percent). Consistent incidences of adverse events were reported from Child-Pugh A and Child-Pugh B7 patients groups with 69 percent and 67 percent, respectively. Commonly reported drug-related adverse reaction from Child-Pugh B7 group was diarrhea (27 percent), hand-foot syndrome (20 percent) and fatigue (16 percent). And in the subgroup analysis of GIDEON on 482 Korean patients, the safety profile was consistent in Child-Pugh A patient group (56.8 percent) and Child-Pugh B patient group (21.8 percent). The subgroup analysis found overall patient group treated with sorafenib (n=482), including Child-Pugh B patients, reached median overall survival of 8.5 months, which was not too far off from the median overall survival of 10.2 months in Child-Pugh A patients only group. Commonly referred by cancer academics, the U.S. National Comprehensive Cancer Network (NCCN) Guidelines (Version 3.2019) and HCC Treatment Guideline in Korea (2018) recommends Nexavar as systemic treatment for HCC patients with specific tumor condition including Child-Pugh A and B7 class of liver function. Professor Kim Yoon Jun of Gastroenterology Department at Seoul National University Hospital commented, “Preserving the liver function is crucial in HCC treatment, but patients with already dysfunctional liver or cancer-damaged liver had not have many treatment option. However, even the patients with severe liver condition, who used to be inaccessible to systemic anticancer therapy, can now access to higher level treatment option with expanded reimbursement.”
- Company
- Daewoong launches 'Nabota' Phase III clinical trial in China
- by An, Kyung-Jin Jan 02, 2020 11:26pm
- On the 28th, Sung-soo Park , Director of Nabota Business Division, Daewoong Pharm. Co., Ltd (Third left in front row) is taking commemorative photos with the researchers such as Yu-ri Pan, professor of dermatology (Fourth left in front row) of Zhejiang Provincial PeopleNabota, a botulinum toxin preparation developed by Daewoong Pharm. Co., Ltd (CEO Seung-ho Jeon), has begun preparations for clinical trials in China. Daewoong Pharm. Co., Ltd announced on the 31st that it held a researcher meeting for Nabota's phase III clinical trials in China at the Pullman Skyway Hotel in Shanghai on the 28th. Daewoong Pharm. Co., Ltd aimed to release the product in 2022 after acquiring Nabota's moderate to severe frown lines improvement indications in China. Daewoong Pharm. Co., Ltd plans to demonstrate non-inferiority and safety by comparing Nabota with the reference drug for 16 weeks in 500 patients with moderate or higher frown lines. The clinical trials will be conducted in 12 institutions, including the 9th Hospital of Shanghai Jiao Tong University, which is famous for its plastic surgery in China. Around 60 people attended the meeting, including professors in the 9th Hospital of Shanghai Chung-Ang University Hospital including the chief clinical officer of China, Chung Bong Lee, clinical researchers and hospital staff. In addition to the announcement of China's Phase III trial plan and questions and answers, Nabota products and clinical trial experiences were introduced. In order to improve understanding of the product and clinical trials, Dr. Won-Woo Choi, a dermatologist of the Wells Dermatology Center, conducted a training program to assist in the launching of clinical trials such as the method for evaluating the frown lines. Chung Bong Lee, Professor of the 9th Hospital of Shanghai Chung-Ang University Hospital said, “2020 is the most anticipated time of change in the medical beauty market. Many people are looking forward to new products, and Nabota will strive to become a successful importer of botulinum toxin in China”. Sung-Soo Park, director of Nabota Business Division, Daewoong Pharm. Co., Ltd, said, “China has the largest number of patients in the world, while its market penetration rate is as low as 2%. The market is expected to grow the most in the future because there are only two licensed drugs. If a high-quality, reasonably priced product, such as Nabota, is officially approved and supplied to the market, Chinese potential patients will be able to receive botulinum toxin procedures more easily and safely”.
- Company
- What's the court ruling on the claim of CSO's money?
- by Jung, Hye-Jin Jan 02, 2020 06:05am
- Medical personnel who received rebates from the CSO in exchange for prescriptions of drugs pleaded not guilty in medical law, the court was found guilty. Doctors insisted that the money they received could not be rebated because the CSO was not a 'medical supplier' as defined by the Medical Law, but the court found that the amount provided by the pharmaceuticals and the CRO planning to offer the rebate was also guilty. The Seoul Western District Court sentenced the fines and penalties for medical doctors A and B last October. A and B, the head of the hospital of X hospital, accepted a proposal from a pharmaceutical company, CSO C, who was in charge of sales agency, saying that prescription of medicines will be given a certain amount of cash and meals. They were caught receiving cash of ￦4.5 million and ￦4.7 million respectively. Doctor A and B pleaded not guilty because ▲ the person who gave the money was not a drug provider, and ▲the individual did not use the money received. In particular, doctors A and B suggested that the amount received from the CRO cannot be rebate, and presented Article 23-2 of the Medical Act and Article 23-3 of the Medical Act. Defendants said that all medical laws prohibit medical workers and others accepting money, etc. from 'pharmaceutical suppliers' (according to Article 47, paragraph 2 of the pharmaceutical affairs law). One argued that money did not apply to this decree. It was argued that money received from a CSO sales person, not a drug supplier, does not fall under this law. The issue was whether the receipt of money from a CSO sales representative would not fall under the requirements of Article 23-2 of Article 2 of Medical Law and Article 23-3 (1) of Medical Law. Prosecutors in charge of the case were reportedly submitted to the Tribunal after investigating the meaning, background, role, problems, and actions of the government and related associations. The court did not accept all the claims of the doctors based on all the evidence. The judiciary said, “Even if the person who provided the money was not a drug supplier, it was processed in a violation of the pharmacist law, & CSOs are no problem in evaluating them as drug providers, CSOs can be evaluated as a drug provider if they can evaluate the degree of participation of CSO officials, the contents of collusion between drug companies and CSO officials, and the sharing of behaviors as joint norms”. Based on the data submitted to the court, between the pharmaceutical company's employees and the CSO officials, the company planned to receive money from the pharmaceutical company in the name of agency commission and pay most of it as a rebate to medical workers. This proved to be the case. The Tribunal decided that CSOs can be evaluated as drug providers and CSO can be seen as a co-criminal recognizing the fact that the CSO received commissioned money in the name of the agency commission, most of it was provided to the medical workers for rebates. The Tribunal also did not acknowledge that doctors claimed that the money they received from the CSO was used to run hospital wards, not individuals. The court judged, “Even if there is a part of the money received and belonged to other members, it does not exclude it from the economic benefits of Doctor A and B. It does not mean that the money belongs to the hospital, which is a medical institution”. The judiciary's judgment is that the hospital staff is an autonomous organization run by the hospital's affiliates and doctors, and is not an official organization of the hospital. In addition, it was hard to say that money was spent on the operation of the legislature due to the lack of substance and the lack of grouping, and there was no evidence that the money was distributed regularly to the members of the legislature. In addition, Doctor A and B, the head of the hospital, suggested that they realistically present drug prescription guidelines and influence residents’ prescriptions. The statement that the pharmaceutical offered them money also affected the ruling. The court pointed out that “after the defendants were paid directly, they used it as expenses for the members of the legislature, such as event expenses, and even if they knew it, it was only a consumption method after the violation of medical law”.
- Company
- Round 2 of Eliquis pricing reduction litigation to begin
- by Kim, Jin-Gu Jan 01, 2020 10:35pm
- Bristol-Myers Squibb (BMS) has decided to make an appeal after losing the Eliquis (apixaban) pricing reduction litigation suit. The twice postponed Eliquis pricing reduction could be postponed, yet again. According to pharmaceutical industry sources, BMS has filed an appeal on Dec. 23 at Seoul High Court. Seemingly, the legal dispute between Ministry of Health and Welfare (MOHW) and BMS over Eliquis would continue. Seoul Administrative Court on Dec 19 rejected the litigation BMS filed against Minister of Health and Welfare to revoke the decision to adjust maximum reimbursed price, and ruled favorable to the defendant, MOHW. Accordingly, the maximum reimbursed price of Eliquis was supposed to be reduced by 30 percent, down to 830 won per tablet, from Jan. 1 next year. MOHW also announced it would postpone the new pricing of Eliquis until Dec. 31. However, the table has turned as BMS is appealing the court ruling. The drug pricing reduction could be postponed for three times. Legal experts say the suspension of drug pricing reduction is limited to each trial. Therefore, BMS may now request for another suspension of the execution as the company is to start another trial. However, it is still unclear if Seoul High Court would accept BMS’ request of suspension. Previously, the court accepted the request most of the times, but in some cases it had not. Regardless, the industry sources predict the ministry would take a reserved action as MOHW itself is unsure of the result of the second trial. In case the ministry loses the second trial after lowering the drug’s price on Jan. 1, the drug price would drop to 830 won and rise back up again to 1,185 won. The sources say the ministry would probably maintain the present pricing to minimize the confusion. A pharmaceutical industry insider analyzed ”The BMS’ appeal has double intentions. The company wants to revoke the ministry decision, while it delays the actual pricing reduction point as much as possible.” The current law states the original’s maximum reimbursed price is to be lowered by 30 percent from the point of same class generic is available, and it is to be brought down to 53.55 percent of the original price from the following year and on. As apixaban generic was launched in June, MOHW had initially planned to lower the price of Eliquis from 1,185 won to 830 won by 30 percent, starting from July 1. However, the reduction was postponed, when BMS requested for suspension of the execution on July 1, and the court accepted the request on July 19. The ministry stated the grace period would end on Dec. 31.
- Company
- The NPS, strengthen management intervention of companies
- by Chon, Seung-Hyun Dec 31, 2019 06:45am
- The nation's largest institutional investor, the National Pension Service declared that it will actively participate in management of investment companies. Starting next year, the possibility of exercising shareholder rights, such as dismissal of directors, will be raised against “bad companies” that violate laws such as embezzlement and resignation. Pharmaceutical bio companies with high stakes in the national pension will also be affected by their participation in national pension management. The National Pension Fund Management Committee held the ninth meeting in 2019 to deliberate and decide on the Guidelines for Active Shareholder Activities. This is a follow-up to the Principles for National Pension Depositary Responsibilities implemented in July last year. The stewardship code is an action guide for the institutional investors, such as pension funds, to faithfully fulfill the responsibilities of trustees, including shareholder activities, for the benefit of the citizens. The active shareholder activity guideline is based on the decision and implementation of the shareholder proposal by the Fund Management Committee within the scope of the Commercial Law and Capital Markets Act. If a pension-invested company undermines corporate value such as embezzlement or labor, and the company does not make efforts to improve it, the national pension may offer a shareholder proposal such as moving away from the company or changing its articles of incorporation. Active pension shareholders' activities are divided into key management issues and unexpected concerns. Key management issues include corporate dividend policy, adequacy of executive remuneration limits, embezzlement and directions, such as damage to corporate value, violation of shareholders' rights, and continuous exercise of voting rights. The National Pension Service will carry out four levels of trustee responsibility activities: private conversation target companies, private key management companies, public key management companies, and shareholder proposals. Unforeseen issues are those that may cause unforeseen damages to corporate values or shareholder rights in relation to the environment, society and governance. Large-scale industrial accidents or severe environmental damage are included. Unexpected concerns go through two stages: selection of companies to be closed talks and shareholder proposals. Neung-hoo Park, The Minister of Health and Welfare said, “The main purpose of the 'Active Shareholder Activities Guidelines' that the National Pension Plan is to create is not to intervene or interfere with corporate management, and it is to improve the profitability of the National Pension System by solving problems through dialogue with companies to increase corporate value and shareholder value”. However, the business community criticizes the national pension as a management intervention. This is because, depending on the will of the National Pension, there is more room to interfere with management such as the removal of directors and the change of articles of incorporation. The Federation of Korean Industries criticized on the day, “If the national pension increases involvement in corporate management and interference with corporate governance, the business activities of companies that have to concentrate on entering new industries and creating jobs will be reduced, and the vitality of our economy will be lost”. As of the end of 2018, national pension investment pharmaceutical bio companies and their shareholdings (Source: The National Pension Service)Pharmaceutical bio companies with high stakes in the National Pension will also be affected by management intervention. As of the end of last year, there are eight pharmaceutical bio companies with more than 10% of the national pension, including Dong-A Socio Holdings, Dong-A ST, Kolmar Korea, Chong Kun Dang, SK Chemicals, Suheung, Yuhan, and Hanmi Pharmaceutical. A total of 22 pharmaceutical bio companies have more than 5% of the national pension. Dong-A Socio Holdings and Dong-A ST, who have the largest stake in the national pension, have faced opposition from the national pension. In 2013, when Dong-A Pharm attempted to split the company into a holding company system, the National Pension Service, which owns a 9.5% stake, then voted against it. The split of the old Dong-A Pharmaceutical is divided into the holding company 'Dong-A Socio Holdings', 'Dong-A ST' in charge of specialty medicines, and 'Dong-A Pharmaceutical', including the general medicine business division, including Bacchus. Dong-A Pharm is a wholly owned subsidiary of the holding company. At the time, the National Pension Service rejected the agenda item, saying, “Because the Bacchus division, which earns 50% of its operating profit from Dong-A Pharm's cash cows, becomes a privately held company, there is a risk of losing shareholder value, despite opposition from the three major shareholders pensions, Dong-A Pharm managed to split 73.38% of the shares in the extraordinary shareholders' meeting”. However, it is also observed that major pharmaceutical bio companies, such as large pharmaceutical companies, have stable control through the change of holding company structure, so that the active shareholder activity of the National Pension will not be a threat. In March, the National Pension Service voted against some agenda at the regular shareholders' meetings of seven pharmaceutical bio companies, including Dong-A ST, Dong-A Socio Holdings, Hanmi Pharmaceutical, Samsung BioLogics, Celltrion, and Seoheung, but all passed by the original plan.
- Company
- Pharmaceuticals produced an average of 58 drugs 2018
- by Chon, Seung-Hyun Dec 30, 2019 06:19am
- Last year, Korean pharmaceutical companies produced 58 finished drugs on average. The amount produced per item was only ₩900 million. Among the three in 3 pharmaceutical companies, the proportion of small-scale pharmaceuticals are high, with the annual output of less than ₩1 billion. According to the '2019 Statistical Yearbook of Food and Drugs,' published by the Ministry of Food and Drug Safety on the 27th, the finished drug production totaled ₩18.5 trillion last year. It was 5.7% higher than 2017's ₩17.6 trillion. In 2010, it increased by 30.3% from ₩14,2 trillion in 2010. Last year, there were 19,239 products produced. In 2017, 52 fewer than 19,291, but 3,266 up from 15,973 in 2010. In 2018, the production performance of each drug product is calculated to be ₩ 963.86 million. Although it is gradually expanding from ₩891.17 million in 2010, it is still small scaled. Finished drug production in 2018 (left) and output per item (right) (Unit: ₩ million, Source: the Ministry of Food and Drug Safety) Last year, there were 329 drug manufacturers. Although 28 fewer than the previous year, 59 more than 270 in 2010. In 2018, an average of ₩56.4 billion of drug production was recorded per pharmaceutical company, and 58 items were produced on average. In general, domestic pharmaceutical companies handle various products and do not escape from department store management, which generates small sales per item. Drug producers (left) and number of items (right) in 2018 (Unit: numbers , Source: the Ministry of Food and Drug Safety) In fact, there were a lot of small companies that did not have a good record of finished drug production. Out of 329 drug product producers in 2018, the company recorded 32.5% of the total production of less than ₩1 billion. One out of three is a small company with less than ₩1 billion in drug production. 166 companies with less than ₩10 billion in production recorded more than half of the total. A total of 48 companies with over ₩100 billion in finished drug production were reported. More than ₩500 billion were in six places. Number of firms by size of finished drug production in 2018 (unit: Numbers , source: the Ministry of Food and Drug Safety)
- Company
- Boryeong’s copyright of anti-cancer drug,commercial value↑
- by An, Kyung-Jin Dec 27, 2019 06:28am
- The anti-cancer drug 'Zepsyre', which is owned by Boryeong in Korea, has entered the early stage of commercialization. PharmaMar, the original developer, is expected to secure the first FDA indication for small cell lung cancer by August next year. The company also won a large contract worth up to ₩640 billion to surpass the US copyright, which is expected to be released the fastest. Boryeong signed a domestic exclusive promotional license agreement for Zepsyre from PharmaMar in November 2017. In 2016, the company signed a monopoly on sales and development of a myeloma treatment drug, Aplidin, to build a strong partnership. According to the industry on the 26th, Borm Pharmaceutical's partner, Spanish PharmaMar, recently signed a monopoly license agreement with jazz pharmaceuticals’ Lurbinectedin. Lurbinectedin is the ingredient name of 'Zepsyre', an ovarian cancer drug introduced by Boryung in November 2017. It selectively exhibits anticancer activity by inhibiting the cause of cancer. It is a mechanism that selectively inhibits the oncogenic transcriptional processes activated in cancer cells and tumor-associated macrophages (TAM) and causes cell death by cutting DNA double strands. With the deal, PharmaMar secured a $200 million deposit (approximately ₩232.2 billion) from Jazz with no obligation to return. When Zepsyre is licensed to sell the US Food and Drug Administration (FDA), it will receive up to $250 million in additional technology charges (milestones). In the future, commercial milestones were guaranteed up to $550 million in technology fees and sales royalties ranging from late 10% to 30%. Jazz is a well-known company that is a partner of 'Sonosi (Solriamfetol)', a sleep disorder new drug exported by SK Biopharm. In the industry, Jazz has secured a huge short-term milestone from Zepsyre's US market potential. PharmaMar submitted a new drug application (NDA) to the US Food and Drug Administration (FDA) on the 17th, based on the results of the second phase clinical trial of Zepsyre. According to PharmaMar's announcement of the American Society for Clinical Oncology (ASCO 2019) in June, patients with small cell lung cancer who received Zepsyre had a significant improvement in tumor response rate (ORR) of 35.2% compared to currently available Topotecan (16.9%). In addition to small cell lung cancer, various cancers including ovarian cancer, head and neck cancer, and BRCA mutation breast cancer are being actively researched. In recognition of this potential, the company signed a licensing agreement with Luye pharmaceutical of China (including Hong Kong and Macao) in April of this year. PharmaMar's executives are confident in the FDA's rapid approval. Small cell lung cancer monotherapy, a rare disease with high unmet demand, has secured positive clinical results. Zepsyre was designated by the FDA in August last year as a rare drug for small cell lung cancer. PharmaMar expects to receive the FDA's final approval in mid-August when the document is completed early next year and undergoes a six-month quick review process. Since then, the aim is to expand the indications to various carcinomas including ovarian cancer, head and neck cancer, and breast cancer. Bruce Cozadd, Chief Executive Officer of Jazz Pharmamaticals, said, “The treatment is limited in patients with advanced small cell lung cancer. The agreement is significant because it expands the jazz anticancer pipeline and later stage assets”.
- Company
- Discontinued sales of Champix generics
- by Kim, Min-Gun Dec 27, 2019 06:27am
- Anti-smoking drug Champix by Pfizer KoreaPfizer's Champix (Varenicline) salt-changing patent disputes have resulted in the loss of more than 20 domestic pharmaceutical companies, which has resulted in the suspension and recovery of generic drugs. According to the industry on the 24th, Hutecs Korea, C-tri, Danajen announced that they will be discontinued due to the result of a material patent evasion lawsuit by salt change of Champix This is because the patent court recently decided that “Champix generic anti-smoking drugs belong to products that differ from champix in the scope of the original material patent rights”. The ruling halted sales and prescriptions of generic products in response to a preliminary order to prohibit patent infringement. Increasingly, pharmaceutical companies are withdrawing from the market. Hutecs has discontinued its sales of 0.5mg (11 tablets, PTP packaging) and 1mg (28 tablets, PTP packaging) sold by the company. “It was due to the loss in the patent evasion litigation by changing the champix salt”, the company explained. In addition, Hutecs requested to block the code so that it is not sold to wholesale trade or nursing homes and to treat as a normal return although not subject to compulsory recall but due to discontinuation. C-tri has decided to discontinue the production of 0.5mg and 1mg of nicotine tablets. C-tri announced that there will be no future reproduction after the stock runs out and excluded from contract sales items. Danajen also stopped selling 0.5mg and 1mg of its Nicotine tablets on the 20th and began to collect all items. Danajen decided to complete the collection by the 15th of next month. In addition to coverage result of Dailypharm, the top domestic pharmaceutical companies that sell Champix generics have withdrawn from the market or are doing the same action. JW Shinyak, Chong Kun Dang, Daewoong Pharmaceutical, and Il Dong Pharmaceutical Co., Ltd ceased production and marketing. One of the pharmaceutical companies said, “We stopped prescribing and selling on the 23rd and will start returning products to pharmacies in the future, Other pharmaceutical companies also blocked both orders and sales”. An official from the PR team in Korea, who had completed the recall, said, “After the solicitation of Solifenacin, we finished preparations for the suspension and recovery early. Some pharmaceutical companies are quick to determine the profitability compared to marketing costs because they are unable to use the strategy to avoid salt changes”. On the other hand, there were some companies still watching the situation. A public relations executive at a mid-size pharmaceutical company said, “The sales department continues to sell, and we have not taken action yet”.
- Company
- Kyowa Kirin Korea appoints Lee Sang Heon as next CEO
- by Eo, Yun-Ho Dec 26, 2019 06:30am
- 이상헌 신임 사장 On Dec. 20, Kyowa Kirin Korea announced the promotion of current Chief Operating Officer Lee Sang Heon (54) as a Chief Executive Officer from Jan. 2, 2020. Graduated from Seoul High School and Yonsei University majoring in bioengineering, soon-to-be CEO Lee Sang Heon had experience in marketing and business alliance in Boryung Pharmaceutical and JW Pharmaceutical. Since April of 2010, Lee joined Kyowa Kirin Korea as a director of management and planning and successfully served his role in business management, project development, and compliance. After being promoted as an executive managing director in 2017, CEO Lee was later appointed as COO and contributed Kyowa Kirin to secure its market leadership in the special disease treatment sector like hemato-oncology and nephrology in Korea. The current CEO Na Jong Cheon is to resign at the end of 2019.
- Company
- Roche sets sail for more trials on Xofluza
- by Eo, Yun-Ho Dec 24, 2019 06:13am
- Following the two decade-long heritage of Tamiflu, next generation flu treatment Xofluza is quickly taking next steps to secure its market position. According to the related industry source on Dec. 24, Roche is to soon present two Phase 3 trial results of Korean health regulator-approved Xofluza (baloxavir), and the company also is prepping for three other clinical trials. The completed trials have tested efficacy of the treatment in a post-exposure prophylaxis study and on high-risk children. The post-exposure prophylaxis study tested the rate of virus transmission from an influenza virus-infected household member to Xofluza-treated household. The result found an arm treated with Xofluza significantly reduced the risk of people developing flu by 86 percent. Clinical trial MINISTONE confirmed positive effect of Xofluza, evaluating virus titer and the time to alleviation of symptoms on pediatric patients aged one to 12 with treatment of the flu treatment. Moreover, Xofluza is also currently calling for clinical trial participants for three other trials. One of the three trials is to study the treatment effect on infant patients under the age of one, whereas the second one titled FLAGSTONE is to observe arms treated with either Xofluza only or Xofluza and the standard of care Tamiflu together as a combination on hospitalized patients. The FLAGSTONE trial is designed to administer Xofluza once on day 1, day 4, and day 7, respectively, for three times total. CENTERSTONE, the last one out of the three trials, is to evaluate preventive effect of Xofluza on patient’s virus transmission. Unlike the post-exposure prophylaxis study, the third trial is to administer the treatment on the patient only and observe not only the patient’s time to alleviation of symptoms, but also the virus transmission among the patient’s household members. When the three trials complete with satisfying results, indications for Xofluza would expand remarkably. Professor Lee Jae-gab of Hallym University Medical Center Infectious Disease Department commented, “Besides the advantage of convenient one-dose oral administration, Xofluza is expected to be used for various indications as it has a different mechanism of action compared to other existing options”. Xofluza has been approved by Korea’s Ministry of Food and Drug Safety (MFDS) in November for treating adult and pediatric patients aged over 12 with Type A and B influenza infections.
