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Incyte today announced that the US FDA has approved Opzelura (ruxolitinib) cream for short-term and non-continuous long-term treatment of patients with mild to moderate atopic dermatitis (AD) over 12 years old
The US FDA's approval is based on two randomized, double-blind, vehicle-controlled Phase 3 clinical trials involving more than 1,200 adolescent and adult patients with mild to moderate AD
▲Primary endpoint results of Rucotinib cream in two phase 3 clinical trials (picture source: reference [2])
Atopic dermatitis is a serious chronic and recurrent skin disease
Rucotinib Cream is a proprietary external formulation of JAK1/JAK2 selective inhibitor Rucotinib
▲The association between atopic dermatitis and JAK signaling pathway (picture source: reference [2])
Reference materials:
[1] Incyte Announces US FDA Approval of Opzelura™ (ruxolitinib) Cream, a Topical JAK Inhibitor, for the Treatment of Atopic Dermatitis (AD).
[2] Ruxolitinib Cream: Phase 3 Data in Atopic Dermatitis.
(The original text has been deleted)