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HEMLIBRA® Granted Priority Review by FDA

June 6, 2018

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