Priority Review for Hemlibra in new hemophilia A indication

Roche (SIX:ROG; OTCQX:RHHBY) said FDA accepted and granted Priority Review to its sBLA for Hemlibra emicizumab-kxwh to treat hemophilia A in adults and children without Factor VIII inhibitors. Its PDUFA date is Oct. 4.

FDA is basing its review in part on on the Phase III HAVEN 3 study, in which Hemlibra met the primary endpoint of reducing treated bleeds over time vs. no prophylaxis in patients without inhibitors. The drug, a bispecific mAb that binds Factor IXa and Factor X, has FDA breakthrough therapy designation in the indication (see BioCentury Extra, May 21)...