FDA accepts new drug application for Gene Tektronix XOFLUZA ™

recently, Roche Group member GeneTec announced that the U.SFoodmedicines(http://Administration (
FDA(http://) has accepted the xOFLUZa ™ (baloxavir marboxil) supplement
new drug(http://application sNDA -- a single-dose oral treatment for people at high risk of flu complicationsexpect sits to be approved by the FDA by November 4, 2019About XOFLUZA
XOFLUZA is a single-dose oraldrug(http:// with a new mechanism of action that has been played in a variety of influenza viruses Unlike other antiviral therapies currently available, XOFLUZA is a new class of antiviral drugs designed to inhibit polymerase acid nucleic acid endoenzymes, an enzyme necessary for viral replication sNDA is based on the results of phase III CAPSTONE-2 clinical studies based on single-dose XOFLUZA 　　About CAPSTONE-2
CAPSTONE-2 is a multicenter, randomized, double-blind Phase III clinical study that evaluates the efficacy and safety of 2,184 high-risk influenza populations with complications of 12 years of age or older in single-dose XOFLUZ compared to placebo and oseltamivir main endpoint is to measure the time of improvement in flu symptoms to assess the efficacy of single doses of XOFLUZA and placebo The secondary endpoint is to compare the efficacy of XOFLUZA with placebo or oseltamivir, including the time of treatment for fever, the time at which the virus is stopped, the time detected in the nasal and throat swabs (http:// the time of the infection virus, antibiotic prescriptions and flu-related complications 　　In CAPSTONE-2, XOFLUZA was well tolerated, no safety signals were found, and the overall incidence of adverse events (25.1%) was low