【速递】史上最强流感药物进入中国IND
1.药融数据，Pharnex Datamonitor最新监测显示，日本盐野义（SHIONOGI ）和罗氏制药开发的最新流感药物-Baloxavir Marboxil-在中国申请IND。针对： influenza A and influenza B。
受理号 | 药品名称 | 药品类型 | 申请类型 | 注册分类 | 企业名称 | 承办日期 |
JXHL1800159 | Baloxavir Marboxil片 | 化药 | 进口 | 5.1 | SHIONOGI & Co., LTD. SHIONOGI & Co., LTD. Settsu Plant 罗氏（中国）投资有限公司 | 2018-11-30 |
笔者预计不到60个工作日将获得临床批件，更快的在60天内即可开展临床。
2.Xofluza（baloxavir marboxil，曾用代号S-033188）：
一款Cap依赖型核酸内切酶抑制剂，首个口服单剂抗病毒药物（ a single dose）。
Baloxavir marboxil 仅需服用一次，就能减少流感症状的持续时间，并在一天内显著减少病毒脱落。
3.最早在日本批准，2018年2月23日；美国FDA在2018年10月24日批准其上市。
4.附FDA批准新闻：
The U.S. Food and Drug Administration approved Xofluza (baloxavir marboxil) for the treatment ofacute uncomplicated influenza (flu) in patients 12 years of age and older who have been symptomatic for no more than 48 hours.（具体适应症）
“This is the first new antiviral flu treatment with a novel mechanism of action approved by the FDAin nearly 20 years. With thousands of people getting the flu every year, and many people becoming seriously ill, having safe and effective treatment alternatives is critical. This novel drug provides an important, additional treatment option,” said FDA Commissioner Scott Gottlieb, M.D. “While there are several FDA-approved antiviral drugs to treat flu, they’re not a substitute for yearly vaccination. Flu season is already well underway, and the U.S. Centers for Disease Control and Prevention recommends getting vaccinated by the end of October, as seasonal flu vaccine is one of the most effective and safest ways to protect yourself, your family and your community from the flu and serious flu-related complications, which can result in hospitalizations. Yearly vaccination is the primary means of preventing and controlling flu outbreaks.”
Flu is a contagious respiratory illness caused by influenza viruses. When patients with the flu are treated within 48 hours of becoming sick, antiviral drugs can reduce symptoms and duration of the illness.
“When treatment is started within 48 hours of becoming sick with flu symptoms, antiviral drugs can lessen symptoms and shorten the time patients feel sick,” said Debra Birnkrant, M.D., director of the Division of Antiviral Products in the FDA’s Center for Drug Evaluation and Research. “Having more treatment options that work in different ways to attack the virus is important because flu viruses can become resistant to antiviral drugs.”
The safety and efficacy of Xofluza, an antiviral drug taken as a single oral dose, was demonstrated in two randomized controlled clinical trials of 1,832 patients where participants were assigned to receive either Xofluza, a placebo, or another antiviral flu treatment within 48 hours of experiencing flu symptoms. In both trials, patients treated with Xofluza had a shorter time to alleviation of symptoms compared with patients who took the placebo. In the second trial, there was no difference in the time to alleviation of symptoms between subjects who received Xofluza and those who received the other flu treatment.
The most common adverse reactions in patients taking Xofluza included diarrhea and bronchitis.
Xofluza was granted Priority Review under which the FDA’s goal is to take action on an application within an expedited time frame where the agency determines that the drug, if approved, would significantly improve the safety or effectiveness of treating, diagnosing or preventing a serious condition.
The FDA granted approval of Xofluza to Shionogi & Co., Ltd.
The FDA, an agency within the U.S. Department of Health and Human Services, protects the public health by assuring the safety, effectiveness, security of human and veterinary drugs, vaccines and other biological products for human use, and medical devices. The agency is also responsible for the safety and security of our nation’s food supply, cosmetics, dietary supplements, products that give off electronic radiation, and for regulating tobacco products.
更多信息，留言。
参考：
NMPA/CDE；
药融数据，Pharnex Datamonitor;
相关公司公开披露等。