Sun Pharma’s NDA for Deuruxolitinib garners FDA nod: A potential leap for alopecia areata patients


Sun Pharmaceutical Industries Ltd announced that the U.S. Food and Drug Administration (FDA) has officially accepted the New Drug Application (NDA) for their investigational drug, deuruxolitinib. This oral selective inhibitor of Janus kinases JAK1 and JAK2 seeks to offer relief to adults grappling with moderate to severe alopecia areata. With an 8mg twice-daily regimen, Sun Pharma has positioned deuruxolitinib for FDA’s comprehensive review.

Abhay Gandhi, CEO – North America Business at Sun Pharma, voiced the company’s dedication, stating, “At Sun, our mission is to impact patient lives positively. We are optimistic that deuruxolitinib could transform into a pivotal treatment alternative for those battling the persistent nature of alopecia areata daily.”

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The robust NDA for deuruxolitinib finds its foundation in two critical Phase III trials: THRIVE-AA1 and THRIVE-AA2. Engaging over 1200 patients across 135+ clinical trial locations, the data collated from these trials took center stage at the 2023 American Academy of Dermatology (AAD) Annual Meeting. The European Academy of Dermatology and Venereology Congress had previously showcased this data, emphasizing the consistent and potent efficacy of the 8 mg dose of deuruxolitinib throughout both Phase 3 trials. Compared to the placebo, deuruxolitinib portrayed significant strides in achieving the clinically meaningful SALT score ≤20 as early as Week 8, and these results persisted throughout the study’s duration. Patient satisfaction metrics further corroborated this, with a marked preference for the 8mg dose.

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Nicole Friedland, CEO of the National Alopecia Areata Foundation (NAAF), added context to the disease’s impact: “Alopecia areata isn’t just about hair loss. It’s a chronic autoimmune disease with deep psychological repercussions, including depression and anxiety.” Acknowledging the current limitations in treatment options, Friedland expressed enthusiasm regarding the FDA’s evaluation of another possible solution.

Alopecia areata, an autoimmune disorder where the immune system erroneously targets hair follicles, can lead to partial or complete hair loss on the scalp and body. Potentially affecting up to 2.5% of the global populace, both genders, irrespective of age, can develop this condition. Beyond the visible hair loss, alopecia areata can thrust individuals into psychological challenges, accentuating the need for efficient treatments.

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The collaboration between Sun Pharma and the FDA stands as a beacon of hope for those enduring alopecia areata. With comprehensive research and patient-centric approaches, the potential introduction of deuruxolitinib might herald a new era in treatment modalities for this condition.

Key Points:

  • Sun Pharmaceutical’s deuruxolitinib receives acceptance from U.S. FDA for New Drug Application (NDA).
  • Investigational drug targets treatment for adults with moderate to severe alopecia areata.
  • Two pivotal Phase III trials, THRIVE-AA1 and THRIVE-AA2, back the NDA.
  • Alopecia areata affects up to 2.5% of the global population, calling for effective treatments.
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