Sun Pharma Announces US FDA Filing Acceptance of New Drug Application (NDA) For Deuruxolitinib

BILKULONLINE

Mumbai, India and Princeton, N.J., Oct 6: Sun Pharmaceutical Industries Ltd  today announced that the U.S. 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 8mg twice daily regimen of deuruxolitinib for FDA review. 

“At Sun, we are committed to making a difference in the lives of patients,” said Abhay Gandhi, CEO – North America Business, Sun Pharma. “We believe that deuruxolitinib has the potential to be an important new treatment option for people who continue to struggle every day with the chronic nature of alopecia areata.” 

The NDA filing for deuruxolitinib with the U.S. 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 8mg dose compared with placebo. 

“People living with alopecia areata are dealing with more than just hair loss. Alopecia areata is a chronic autoimmune disease with psychological and emotional effects, and there is still significant unmet medical need in the community,” said Nicole Friedland, President and Chief Executive Officer of the National Alopecia Areata Foundation (NAAF).

“We are excited that the FDA is evaluating another potential treatment option for this serious medical condition.”-AA2 (NCT04518995 and NCT04797650) were randomized, double-blind, placebo-controlled clinical trials in 1223 adult patients age 18-65 with moderate to severe alopecia areata at sites in the U.S., Canada and Europe evaluating the regrowth of scalp hair after 24 weeks of dosing using the SALT score.

Patients were randomized to receive either 8 mg twice [1] daily or 12 mg twice-daily of deuruxolitinib or placebo for 24 weeks. The primary endpoint was the percentage of patients achieving a SALT score of 20 or less at 24 weeks.

Patients enrolled in THRIVE-AA1 and THRIVE-AA2 were required to have at least 50 percent scalp hair loss due to alopecia areata, as measured by SALT. A SALT score of 100 represents total scalp hair loss, whereas a score of 0 represents no scalp hair loss. The average baseline SALT score across all patients in THRIVE-AA1 and THRIVE-AA2 was approximately 85.9 and 87.9 respectively.