Incyte : FDA Extends NDA Review Period For Ruxolitinib In Atopic Dermatitis

(RTTNews) - Incyte Corp. (INCY) said Friday that the U.S. Food and Drug Administration has extended the review period for the New Drug Application or NDA for ruxolitinib cream for the treatment of atopic dermatitis.

The Prescription Drug User Fee Act (PDUFA) action date has been extended by three months to September 21, 2021.

In Friday pre-market trade, INCY was trading at $84.50 down $3.03 or 3.46 percent.

The company noted that 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.

Incyte said it is 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.

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.