FDA halts clinical trials of Deuruxolitinib due to the potential for thrombotic events seen in subjects. FDA has placed the IND on partial clinical hold and are requiring that subjects currently on studies to discontinue the dose.
It has been noted by the FDA that pulmonary embolism (Serious Adverse Events) occurring at the 12 mg BID dose in one of the long-term Open Label Extension (OLE) studies of Deuruxolitinib.
Deuruxolitinib is an investigational oral selective inhibitor of Janus kinases JAK1 and JAK2 being studied for the treatment of Alopecia Areata.
Company said, "No thromboembolic events were observed during Phase-2 or Phase-3 trials, and we 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."
FDA has given Deuruxolitinib as Breakthrough Therapy designation for the treatment of adult patients with moderate to severe Alopecia Areata and the US FDA has also granted deuruxolitinib Fast Track designation for the treatment of Alopecia Areata.
