Incyte (NSDQ:INCY) announced today that the FDA extended the review period for the new drug application for its ruxolitinib cream.
Wilmington, Del.-based Incyte designed its ruxolitinib cream to treat atopic dermatitis (AD). The company designed the proprietary formulation of its selective JAK1/JAK2 inhibitor ruxolitinib for topical application, according to a news release.
Currently, the ruxolitinib cream is under evaluation in Phase 3 development for treating adolescents and adults with AD ant vitiligo. Incyte holds worldwide rights for the development and commercialization of the cream.
The FDA extended the Prescription Drug User Fee Act (PDUFA) by three months (to Sep. 21, 2021) to allow for the necessary time to review additional analyses of previously submitted data provided by Incyte in response to a request for information by the FDA. That constitutes a major amendment to the NDA, resulting in an extension.
“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,” Incyte CMO Dr. Steven Stein said in the release.