Takeda gets quick FDA nod for MM drug Ninlaro

FDA approved Ninlaro ixazomib from Takeda Pharmaceutical Co. Ltd. (Tokyo:4502) to treat multiple myeloma (MM), months ahead of its March 10, 2016, PDUFA date. The agency approved Ninlaro in combination with Revlimid lenalidomide from Celgene Corp. (NASDAQ:CELG) and dexamethasone to treat MM in patients who have received at least one prior therapy.

Takeda plans to launch Ninlaro by mid-December at a wholesale acquisition cost (WAC) of $8,670 per 28-day treatment cycle. ...