Roche Leads Pipeline NewsBy
A roundup of the latest market developments from the pipelines of the pharmaceutical majors and other related news, featuring news from Roche.
Editor’s Note: This article is updated on a continuous basis for news announced from Wednesday, August 23, 2017 to Tuesday, August 29, 2017.
FDA Grants Priority Review to Roche’s Hemophilia Drug
The US Food and Drug Administration (FDA) has accepted Roche’s biologics license application and granted priority review for emicizumab, a drug for treating hemophilia A.
It has been approved as a once-weekly subcutaneous treatment for adults, adolescents, and children with hemophilia A with factor VIII inhibitors. According to Roche, nearly one in three people with hemophilia A develop inhibitors to standard factor VIII replacement therapies, which limits treatment options and increases the risk of bleeds and repeated bleeds, particularly in joints, that cause long-term damage.
The FDA is expected to make a decision on approval by February 23, 2018. The FDA granted breakthrough therapy designation for emicizumab in adults and adolescents with hemophilia A with inhibitors in September 2015.