Benzinga | Jun 11, 2021 07:32AM EDT

Incyte Announces FDA Has Extended New Drug Application Review Period For Ruxolitinib Cream For Treatment Of Atopic Dermatitis To Sept. 21 To Allow Time To Review Additional Analyses Submitted In Response To FDA's Information Request

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.