Incyte Announces U.S. FDA Has Extended the New Drug Application Review Period for Ruxolitinib Cream for the Treatment of Atopic Dermatitis

Incyte Corporation (Nasdaq:INCY) announced today that the U.S. Food and Drug Administration (FDA) has extended the review period for the New Drug Application (NDA) for 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.

“We are confident in the potential of ruxolitinib cream to offer a safe and effective treatment option for atopic dermatitis and will continue to work with the FDA to bring this targeted topical therapy to patients in the U.S. as soon as possible,” said Steven Stein, M.D., Chief Medical Officer, Incyte.

About Ruxolitinib Cream

Ruxolitinib cream is a proprietary formulation of Incyte’s selective JAK1/JAK2 inhibitor ruxolitinib that has been designed for topical application. Ruxolitinib cream is currently in Phase 3 development for the treatment of adolescents and adults with atopic dermatitis (TRuE-AD) and vitiligo (TRuE-V). Incyte has worldwide rights for the development and commercialization of ruxolitinib cream.

About Incyte

Incyte is a Wilmington, Delaware-based, global biopharmaceutical company focused on finding solutions for serious unmet medical needs through the discovery, development and commercialization of proprietary therapeutics. For additional information on Incyte, please visit Incyte.com and follow @Incyte.