Sun Pharmaceuticals (NSE:SUNPHARMA) has received a clinical hold from the FDA on its experimental dermatological drug deuruxolitinib over the potential for thromboembolic incidents. The hold pertains to patients taking a 12-mg dose of the Janus kinase (JAK) inhibitor.
Reuters was the first to report the news.Sun Pharma maintains confidence in deuruxolitinib despite FDA clinical hold
“No thromboembolic events were observed during phase 2 or phase-3 trials [of deuruxolitinib], 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,” wrote Dr. Rajiv Malik, president of Sun Pharma, in a statement
Sun Pharma acquired rights to deuruxolitinib through its acquisition of Concert Pharmaceuticals for $576 million earlier this year.
In March, Concert, then recently acquired by Sun Pharma, presented positive data from the phase 3 THRIVE-AA…