US FDA accepts Sun Pharma’s NDA for Deuruxolitinib

Sun Pharmaceutical Industries announced that the US Food and Drug Administration (FDA) has accepted the New Drug Application (NDA) for deuruxolitinib, an investigational oral selective inhibitor of Janus kinases JAK1 and JAK2, for the treatment of adults with moderate to severe alopecia areata. In the NDA, Sun Pharma has submitted 8 mg twice daily regimen of deuruxolitinib for FDA review.

The NDA filing for deuruxolitinib with the US FDA is based on two pivotal Phase III trials (THRIVE-AA1 and THRIVE-AA2), which included over 1200 patients across more than 135 clinical trial sites. Data from these trials were most recently presented at the 2023 American Academy of Dermatology (AAD) Annual Meeting in March and previously presented at the 31st European Academy of Dermatology and Venereology Congress. The presentations highlighted the consistent and high-level efficacy with deuruxolitinib at the 8 mg dose in both Phase 3 trials. Significant differences in achieving the clinically meaningful SALT score ≤20 for treatment arm compared to placebo were seen as early as Week 8 and were maintained throughout the studies. Treatment with deuruxolitinib was generally well-tolerated and patient satisfaction was significantly higher for the 8 mg dose compared with placebo.

Alopecia areata is an autoimmune disease in which the immune system attacks hair follicles, resulting in partial or complete loss of hair on the scalp and body.