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usfda: Sun Pharma files new drug application with USFDA for investigational medicine to treat alopecia


Sun Pharmaceutical Industries Ltd on Friday said the US health regulator has accepted the new drug application for deuruxolitinib, an investigational oral drug for the treatment of adults with moderate to severe alopecia areata. In the new drug application, Sun Pharma has submitted the 8mg twice daily regimen of deuruxolitinib for US Food and Drug Administration (USFDA) review, the company said in a statement.

“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 CEO, North America Business, Abhay Gandhi, said.

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The new drug application filing for deuruxolitinib with the USFDA is based on two pivotal Phase III trials, which included over 1,200 patients, across more than 135 clinical trial sites, the company said.

“Data from these trials were most recently presented at the 2023 American Academy of Dermatology Annual Meeting in March and previously presented at the 31st European Academy of Dermatology and Venereology Congress,” it added.


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