This Specialty TrendsRx Approval Alert focuses on Hemlibra (emicizumab-kxwh).

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Hemlibra [Genentech/Roche] is a subcutaneous injection approved by the U.S. Food and Drug Administration (FDA) on November 16, 2017, for routine prophylaxis to prevent or reduce the frequency of bleeding episodes in adult and pediatric patients with hemophilia A who have developed factor VIII inhibitors.

Hemlibra is the first new medication approved in nearly two decades for patients with hemophilia A with inhibitors. It was granted Breakthrough Therapy designation, which is intended to expedite the development and review of drugs for serious or life-threatening conditions that may demonstrate substantial improvement over existing therapies.