Dr. Reddy's Says Sernivo Spray 0.05% For Plaque Psoriasis Gets FDA Approval

(RTTNews) - Dr. Reddy's Laboratories Ltd. (RDY) announced Monday that its US subsidiary Promius Pharma LLC, U.S. has received approval for Sernivo (betamethasone dipropionate) Spray, 0.05% from the U.S. Food and Drug Administration or FDA.

India-based drug maker noted that Sernivo Spray, a prescription topical steroid, is indicated for the treatment of mild to moderate plaque psoriasis in patients 18 years of age or older.

The commercial launch of the product is planned for the coming quarter.

Promius has conducted two successful multi-center, randomized, double-blind, vehicle-controlled clinical trials in subjects aged 18 years and older with moderate plaque psoriasis to evaluate the safety and efficacy of Sernivo Spray. In both trials, randomized subjects applied Sernivo Spray or vehicle spray to the affected areas twice daily for 28 days.

Treatment success was achieved in significantly more subjects using Sernivo than Vehicle at both Day 15 and Day 29 across both studies.