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

Sun Pharmaceutical Industries announced on Friday that the United States Food and Drug Administration (FDA) has accepted the New Drug Application (NDA) for deucruxitinib, an oral selective inhibitor of Janus kinases JAK1 and JAK2. The NDA sought approval for treating adults with moderate to severe alopecia areata, a chronic autoimmune disease resulting in partial or complete hair loss on the scalp and body.

Sun Pharma's NDA submission comprised data from two Phase-III trials, 'THRIVE-AA1' and 'THRIVE-AA2,' involving over 1,200 patients across more than 135 clinical trial sites. These trials demonstrated the consistent and high-level efficacy of deucruxitinib at an 8 mg dose, showing significant differences in achieving clinically meaningful Severity of Alopecia Tool (SALT) scores compared to a placebo, as early as week 8 and throughout the duration of the studies. Importantly, patients reported higher satisfaction with the 8 mg dose of deucruxitinib than with the placebo.

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Abhay Gandhi, Chief Executive Officer for North America Business at Sun Pharma, stated, "We believe that deucruxitinib has the potential to be an important new treatment option for individuals grappling daily with the chronic nature of alopecia areata."

Nicole Friedland, President and Chief Executive Officer of the National Alopecia Areata Foundation (NAAF), commented, "Alopecia areata is a chronic autoimmune disease with psychological and emotional repercussions, and there remains a significant unmet medical need in the community. We are excited that the FDA is evaluating another potential treatment option for this severe medical condition."

Alopecia areata could affect up to 2.5 per cent of the United States and global population during their lifetimes, causing not just physical but also psychological consequences, such as anxiety and depression. Currently, there are limited treatment options available for this autoimmune disease.

Sun Pharma is the largest pharmaceutical company in India and a leading generic company in both the US and Global Emerging Markets. It is also the world's fourth-largest specialty generics firm, with a presence in Specialty, Generics, and Consumer Healthcare products.