FDA extends review period for another Incyte NDA

The US Food and Drug Administration 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, says the drug’s developer, USA-based Incyte Corp (Nasdaq: INCY), whose shares closed down 5.7% at $82.58 on Friday following the announcement.

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.