FDA approves Genetech's new anti-flu drug, Baloxavir marboxil, for extended indications

Today, Roche's Gene
(http:// announcedthat it had approved an extended indication of its new anti-fludrug(http://, http://theFDA( http://Xofluza will be used to treat people 12 years and older at high risk of flu complicationsThese acute influenza patients develop infection for no more than 48 hours and there are no complicationsAbout Xofluza
Xofluza is a single-dose oraldrug(http:// of "first-in-class" It can work against the resistant strain of oseltamivir and the avian influenza virus strain (H7N9, H5N1) Unlike other anti-flu drugs, which prevent virus transmission through targeted neuraminidase 　　Xofluza inhibits virus replication by inhibiting cap-dependent nucleic acid endenosine (cap-endonuclease) in influenza viruses 　　Currently, baloxavir marboxil has been approved in several different countries for the treatment of influenza A and B in children, adolescents and adults, and in the United States for the treatment of acute and simple influenza in people 12 years and older 　　The approval of this extended indication is based on the positive results of phase 3 trial (http:// CAPSTONE-2 The CAPSTONE-2 trial is designed to assess the effectiveness and safety of Xofluza in treating patients at high risk of influenza complications over 12 years of age compared to oseltamivir or placebo 　　The results showed that In patients at high risk of influenza complications, Xofluza significantly delayed the median duration of flu symptoms (102 hours compared to 73 hours) 　　Other key findings include xofluza having a similar effect on the duration of flu symptoms compared to oseltamivir (54 hours vs 54 hours), and for b viruses, Xofluza improved flu symptoms in a shorter period of time (75 hours vs 101 hours) compared to placebos xofluza demonstrates good tolerance and safety