Chugai’s HEMLIBRA Receives Priority Review Status from U.S. FDA for Hemophilia A Without Inhibitors

Chugai Pharmaceutical (TOKYO:4519) announced today that the U.S. Food and Drugs Administration (FDA) has accepted the supplemental Biologics License Application (sBLA) and granted Priority Review for HEMLIBRA® [US generic name: emicizumab-kxwh] for adults and children with hemophilia A without factor VIII inhibitors. The FDA is expected to make a decision on approval by 4 October, 2018.

As quoted in the press release:

“We are very proud that HEMLIBRA has been granted a second Priority Review for hemophilia A without inhibitors following the previous designation for hemophilia A with inhibitors, which underscores the innovation of this drug,” said Chugai’s Executive Vice President, Co-Head of Project & Lifecycle Management Unit, Dr. Yasushi Ito. “In treatment of hemophilia A without inhibitors, there still remain unmet medical needs in the management of bleeding. Given this Priority Review status, we hope to be able to contribute to people with hemophilia A and their caregivers as soon as possible by providing HEMLIBRA as a new treatment option that can be administered subcutaneously with good bleeding control and eased treatment burden.”

The sBLA filing and Priority Review are based on the results of HAVEN 3 study (NCT02847637), which has been conducted with adults and adolescents with hemophilia A without factor VIII inhibitors under a collaboration between Chugai, Roche and Genentech. In EU, Roche has already filed the results to the European Medicines Agency for a supplemental indication of hemophilia A without inhibitors.

Click here to read the full press release.