Incyte’s ruxolitinib saw a 15-point jump on its Likelihood of Approval (LoA) in vitiligo on the back of positive topline data from two Phase III trials. Ruxolitinib previously had an LoA of 15%, which rose to 23% as of 19 May, two days after Phase III TRuE-V1 and TRuE-V2 data were revealed on 17 May.
In both TRuE-V trials, topical cream ruxolitinib met the primary endpoint of ≥75% improvement from baseline in the facial vitiligo area scoring index (F-VASI75) compared with patients treated with a vehicle control at week 24 (p<0.0001 for both studies). The trials recruited patients aged ≥12 years and over.
Incyte has its eyes on submitting marketing applications for JAK inhibitor ruxolitinib to the FDA and the EMA in 2H21. The FDA is already reviewing an NDA of ruxolitinib in atopic dermatitis with a decision expected in 1H21.
Incyte has an $18.37bn market cap.
Reynald Castaneda is an Associate Editor for Clinical Trials Arena parent company GlobalData’s investigative journalism team. A version of this article originally appeared on the Insights module of GlobalData’s Pharmaceutical Intelligence Center. To access more articles like this, visit GlobalData.