Sun Pharma’s NDA for deuruxolitinib accepted by FDA
India-based pharma company Sun Pharmaceutical Industries has announced that the US Food and Drug Administration (FDA) has accepted its New Drug Application (NDA) for deuruxolitinib for the treatment of adults with moderate-to-severe alopecia areata.
The NDA covers an 8mg dose of the drug to be administered twice daily and is based on two pivotal phase 3 trials, THRIVE-AA1 and THRIVE-AA2. Data from the trials has been previously presented at the 2023 American Academy of Dermatology (AAD) annual meeting in March 2023 and the 31st European Academy of Dermatology and Venereology Congress.
The trials demonstrated a consistent and high-level efficacy of the drug in an 8mg dose, with significant differences in the clinically meaningful SALT score for the treatment arm compared to the placebo group.
Treatment with deuruxolitinib was generally well tolerated.
Nicole Friedland, president and chief executive officer of the National Alopecia Areata Foundation (NAAF), commented: “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. We are excited that the FDA is evaluating another potential treatment option for this serious medical condition.”
“At Sun, we are committed to making a difference in the lives of patients,” said Abhay Gandhi, CEO of 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.”
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