Sun Pharma’s Deuruxolitinib NDA Accepted by FDA for Alopecia Areata.
Sun Pharmaceutical Industries has announced that the United States Food and Drug Administration (FDA) has given the green light to the New Drug Application (NDA) for deucruxitinib, an oral selective inhibitor of Janus kinases JAK1 and JAK2. The NDA’s objective is to secure approval for the treatment of adults with moderate to severe alopecia areata, an autoimmune condition leading to hair loss on the scalp and body.
The NDA submission by Sun Pharma included data from two Phase-III trials, ‘THRIVE-AA1’ and ‘THRIVE-AA2,’ encompassing over 1,200 patients from more than 135 clinical trial sites. These trials showcased the consistent and high-level effectiveness of deucruxitinib at an 8 mg dosage, with significant improvements in achieving clinically meaningful Severity of Alopecia Tool (SALT) scores compared to a placebo, starting as early as week 8 and continuing throughout the studies. Additionally, patients reported higher satisfaction with the 8 mg dose of deucruxitinib compared to the placebo.
On Friday, Sun Pharma’s stock closed at Rs. 1,125, reflecting a 0.53% increase on The National Stock Exchange.