US FDA approves NDA for Sun Pharma’s alopecia drug Deuruxolitinib

In the NDA, Sun Pharma has submitted 8mg twice daily regimen of deuruxolitinib for FDA review.

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Sun Pharmaceutical Industries Ltd said that the U.S. Food and Drug Administration (FDA) has accepted the new drug application (NDA) for deuruxolitinib, an investigational oral selective inhibitor, for the treatment of adults with moderate to severe alopecia areata on October 6.

In the NDA, Sun Pharma has submitted 8mg twice daily regimen of deuruxolitinib for FDA review.

“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,” said Abhay Gandhi, CEO - North America Business, Sun Pharma.

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The NDA filing for deuruxolitinib with the U.S. FDA is based on two pivotal Phase III trials, which included over 1,200 patients across more than 135 clinical trial sites. Data from these trials were 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 according to the company. Treatment with deuruxolitinib was generally well-tolerated and patient satisfaction was significantly higher for the 8mg 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. Alopecia areata may affect up to 2.5 percent of the US and global population during their lifetime.

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“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.”