Roche (SIX: RO, ROG; OTCQX: RHHBY) announced that the US Food and Drug Administration (FDA) has accepted the company's supplemental Biologics License Application (sBLA) and granted Priority Review for Hemlibra® (emicizumab-kxwh) for adults and children with haemophilia A without factor VIII inhibitors. The sBLA is based on data from the phase III HAVEN 3 study. The FDA is expected to make a decision on approval by 4 October 2018.
"People with haemophilia A can face significant challenges in managing their condition and may need to adapt their daily lives to avoid bleeds and accommodate treatment," said Sandra Horning, MD, Roche's Chief Medical Officer and Head of Global Product Development. "We believe the FDA’s decision to grant Priority Review to Hemlibra underscores its potential to improve the standard of care for people without factor VIII inhibitors and to help reduce treatment burden by offering more flexible subcutaneous dosing options. We look forward to working with the FDA to hopefully bring Hemlibra to all people with haemophilia A as quickly as possible."
Read more: http://www.worldpharmanews.com/roche/4436-fda-grants-priority-review-to-roche-s-hemlibra-for-people-with-haemophilia-a-without-factor-viii-inhibitors