Incyte Reports the US FDA’s Acceptance of NDA for Priority Review of Ruxolitinib Cream to Treat Atopic Dermatitis

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  • The NDA is based on two P-III TRuE-AD 1 & 2 assessing ruxolitinib cream (0.75%/1.5%, bid) vs vehicle (non-medicated cream) in 600 patients aged ≥12yrs. in a ratio (2:2:1) diagnosed with AD for at least 2yrs. and who were candidates for topical therapy
  • Patients who completed an assessment @8wks. were offered participation in the 44wks. long-term safety treatment extension period with ruxolitinib cream (0.75%/1.5%, bid)
  • The company submitted PRV along with NDA to the FDA which shortens the review period by 4mos. The anticipated PFUFA date is Jun 21, 2021

Click here ­to­ read full press release/ article | Ref: BusinessWire | Image: BusinessWire

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