Shots:

• 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

 ­ Ref: BusinessWire | Image: BusinessWire