FDA puts partial hold on deuruxolitinib clinical program

Indian drug major Sun Pharma Industries (BSE: 524715) dipped just 1% to 962.60 rupees, despite the company announcing a setback in the development of its newly-acquired product candidate deuruxolitinib – an oral inhibitor of Janus kinases JAK1 and JAK2 for the treatment of alopecia areata, an autoimmune dermatological disease – which is in late-stage development.

Following a recent submission to the US Food and Drug Administration (FDA), Sun Pharm said it had a teleconference call with the agency, regarding a pulmonary embolism (serious adverse events) occurring at the 12mg BID dose in one of the long-term open label extension (OLE) studies with deuruxolitinib.

Sun Pharma, India's largest drugmaker by revenue, acquired deuruxolitinib when it bought USA-based Concert Pharmaceuticals for $576 million earlier this year.