Blueprint's Ayvakit nears another approved indication

Boston, USA-based biotech Blueprint Medicines Corporation (Nasdaq: BPMC) has announced that the US Food and Drug Administration (FDA) has accepted the company's supplemental new drug application (sNDA) for Ayvakit (avapritinib) to treat indolent systemic mastocytosis (SM).

The FDA granted priority review with an action date of May 22, under the Prescription Drug User Fee Act (PDUFA).

Blueprint’s regulatory application is based on results from the global PIONEER trial, the largest randomized, placebo-controlled study ever conducted in indolent SM.