FDA accepts Sun Pharma's NDA for alopecia candidate

Leading Indian drugmaker Sun Pharmaceutical Industries (BSE: 524715) today revealed that the US Food and Drug Administration (FDA) has accepted the New Drug Application (NDA) for deuruxolitinib, an investigational oral selective inhibitor of Janus kinases JAK1 and JAK2, for the treatment of adults with moderate to severe alopecia areata.

In the NDA, Sun Pharma has submitted 8mg twice daily regimen of deuruxolitinib for FDA review. The resubmission comes after the FDA  placed the investigational new drug (IND) on partial clinical hold, due to the potential for thrombotic events, and are requiring that subjects currently on the 12mg BID dose in the OLE studies to discontinue that dose.

Sun Pharma acquired deuruxolitinib when  it bought USA-based Concert Pharmaceuticals for $576 million early this year.