BioCentury
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FDA approves Genentech's Hemlibra for hemophilia A

November 16, 2017 9:21 PM UTC

FDA approved once-weekly subcutaneous Hemlibra emicizumab-kxwh from the Genentech Inc. unit of Roche (SIX:ROG; OTCQX:RHHBY) for routine prophylaxis to prevent or reduce the frequency of bleeding episodes in adults and children with hemophilia A with Factor VIII inhibitors. The approval comes three months ahead of its Feb. 23 PDUFA date (see BioCentury Extra, Aug. 24).

Genentech said the drug will be available "shortly" at a wholesale acquisition cost (WAC) of about $482,000 for the first year of treatment and about $448,000 for each subsequent year for a 58 kg patient...