Sun Pharmaceutical Industries Ltd, a leading drug manufacturer, announced a significant milestone on Friday as the United States Food and Drug Administration (FDA) accepted its New Drug Application (NDA) for deuruxolitinib. This innovative dermatological drug holds promise for treating adults grappling with moderate to severe alopecia areata, an autoimmune condition linked to hair loss. Deuruxolitinib functions as an investigational oral selective inhibitor targeting Janus kinases JAK1 and JAK2, a pivotal group of intracellular enzymes.
The application submitted for FDA review pertains to an 8mg twice-daily dosage of deuruxolitinib. Notably, the NDA draws strength from comprehensive data gleaned from two Phase-III trials, encompassing a staggering 1,200 patients spread across over 135 clinical trial sites.
Abhay Gandhi, the CEO of North America Business at Sun Pharma, expressed the company’s deep-rooted commitment to enhancing patient well-being, stating, “At Sun, we are committed to making a difference in the lives of patients. 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.”
Sun Pharma’s press release shed light on the recent data presentations at the 2023 American Academy of Dermatology (AAD) Annual Meeting in March, as well as the 31st European Academy of Dermatology and Venereology Congress. These presentations underscored the consistent and remarkable efficacy of the 8mg dosage of deuruxolitinib in both Phase-III trials. Additionally, treatment with deuruxolitinib demonstrated commendable tolerability, with significantly heightened patient satisfaction compared to the placebo.
Nicole Friedland, President and CEO of the National Alopecia Areata Foundation (NAAF), expressed her enthusiasm about the FDA’s evaluation of this potential treatment option. She emphasized the multifaceted impact of alopecia areata on individuals, beyond just physical appearance, and highlighted the pressing need for effective medical interventions in the community.
Earlier in May, the FDA had advised Sun Pharma to halt tests on a specific dosage of deuruxolitinib due to concerns regarding blood clot formation. It’s imperative to note that patients with alopecia areata taking the 12mg dose of deuruxolitinib have been advised to discontinue its use. However, reassuringly, Sun Pharma confirmed the absence of blood clot formations in patients receiving the 8mg dose, and the FDA has not imposed any hold on these particular trials. This development marks a crucial step forward in the quest for an effective solution for those affected by alopecia areata.
About Sun Pharma:
Sun Pharmaceutical Industries is engaged in the business of manufacturing, developing and marketing a wide range of branded and generic formulations and Active Pharma Ingredients (APIs). The company and its subsidiaries has various manufacturing facilities spread across the world with trading and other incidental and related activities extending to global market. It is the largest pharmaceutical company in India.
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