Sun Pharmaceutical Industries Limited had a teleconference call with the agency, regarding a pulmonary embolism (Serious Adverse Events) occurring at the 12 mg BID dose in one of the long-term Open Label Extension (OLE) studies. As a result, the agency has placed the IND on partial clinical hold, due to the potential for thrombotic events, and are requiring that subjects currently on the 12 mg BID dose In the OLE studies to discontinue that dose. There have been no thrombotic events reported to date for the 8 mg BID dose and US FDA has not placed the 8 mg BID dose on hold.

The company is taking immediate steps to transition the patients in the OLE studies to the 8 mg BID dose arm in the ongoing studies. No thromboembolic events were observed during Phase-2 or Phase-3 trials, and remain confident in deuruxolitinib's potential to treat patients with Alopecia Areata and will work closely with the US FDA to address the agency's concerns. US FDA is expected to state the concerns in a formal letter, expected within the next 30 days.

Deuruxolitinib is an investigational oral selective inhibitor of Janus kinases JAK1 and JAK2 being studied for the treatment of Alopecia A treata. In addition to Breakthrough Therapy designation for the treatment of adult patients with moderate to severe Alopecia Areat a, the US FDA has also granted deuruxolitinib Fast Track designation for the treatment of AlopECia Areata.