Dr. Reddy’s Laboratories announced that the Food and Drug Administration (FDA) has approved Impoyz (clobetasol propionate) Cream 0.025%, formerly DFD-06, for the treatment of moderate to severe plaque psoriasis in patients aged ≥18 years.
Impoyz Cream is a high potency topical steroid. Corticosteroids play a role in cellular signaling, immune function, inflammation, and protein regulation. Its precise mechanism of action in corticosteroid responsive dermatoses is unknown, however.
The FDA approval was supported by data from 2 double-blind, randomized, vehicle-controlled trials (N=532) in patients with moderate to severe plaque psoriasis (IGA 3 or 4 and BSA ≥3%).
Patients were treated twice daily with Impoyz Cream or vehicle for 14 days and were assessed for treatment success at Day 15, defined as IGA score of 0 (clear) or 1 (almost clear) with at least a 2-grade reduction from baseline.
In Trial 1, 30.2% of Impoyz-treated patients achieved treatment success vs 9.0% in the vehicle group. In Trial 2, 30.1% of Impoyz-treated patients achieved treatment success vs 9.7% in the vehicle group. The most commonly reported adverse effect was discoloration of the treated site.
Impoyz Cream will be available as a 0.025% cream in 60g and 112g tubes.
Dr. Reddy’s announces approval of Impoyz (clobetasol propionate) cream, 0.025% first-cycle NDA approval [press release]. Hyderabad, India; Dr. Reddy’s Laboratories: December 1, 2017. Accessed December 5, 2017.
This article originally appeared on MPR