Donate

industry_news_banner

Note: The following is an edited version of a press release from Genentech.聽Read the press release from Genentech聽in it鈥檚 entirety here.


Genentech, a member of the Roche Group, announced today that the U.S. Food and Drug Administration (FDA) has accepted the company鈥檚 Biologics License Application (BLA) and granted Priority Review for emicizumab prophylaxis (preventative) as a once-weekly subcutaneous treatment for adults, adolescents and children with hemophilia A with factor VIII inhibitors.聽The FDA is expected to make a decision on approval by February 23, 2018. Priority Review designation is granted to medicines that the FDA has determined to have the potential to provide significant improvements in the safety and effectiveness of the treatment, prevention or diagnosis of a serious disease. The FDA granted Breakthrough Therapy Designation for emicizumab in adults and adolescents with hemophilia A with inhibitors in September 2015.


Sign up for E-mails, Dateline Magazine, and other ways to stay connected.