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FDA delays PDUFA action date for Jakavi in atopic dermatitis.- Incyte

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Published:12th Jun 2021
Incyte Corporation announced that the FDA has extended the review period for the New Drug Application (NDA) for Jakavi (ruxolitinib cream) for the treatment of atopic dermatitis (AD).

The Prescription Drug User Fee Act (PDUFA) action date has been extended by three months to September 21, 2021. The FDA extended the PDUFA action date to allow time to review additional analyses of previously submitted data provided by Incyte in response to the FDA’s information request. The submission of the additional information has been determined by the FDA to constitute a Major Amendment to the NDA, resulting in an extension of the PDUFA goal date. The NDA is supported by data from the Phase III TRuE-AD clinical trial program, which included more than 1,200 people, age 12 years and older. Primary efficacy and safety results from both TRuE-AD trials were presented at the Revolutionizing Atopic Dermatitis Virtual Symposium in April 2020. Additional safety and efficacy data from the 44-week, open-label, long-term extension of both TRuE-AD1 and TRuE-AD2 were included in the NDA.

Condition: Atopic Dermatitis (Eczema)
Type: drug

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