HEMLIBRA® Granted Priority Review by FDA
Roche Holding AG announced that the US Food and Drug Administration (FDA) has granted “priority review” to HEMLIBRA®, a subcutaneously administered therapy currently being investigated for the treatment of patients with hemophilia A without factor VIII (FVIII) inhibitors. The therapy, which is co-developed by Genentech, Chugai and Roche, is already FDA-approved for routine once-weekly prophylaxis to prevent or reduce the frequency of bleeding episodes in adults and children with hemophilia A with FVIII inhibitors.
Priority reviews are expedited appraisals of drugs that take less time than standard applications. According to a recent press release, this priority review is specifically for adults and children with hemophilia A without FVIII inhibitors. The FDA is expected to decide on approval by October 4, 2018.
Source: MarketWatch, June 5, 2018