Indian-based Dr Reddy’s Laboratories’ US subsidiary Promius Pharma has received approval from the US Food and Drug Administration (FDA) for Sernivo (betamethasone dipropionate) Spray, 0.05%, to treat mild to moderate plaque psoriasis in patients aged 18 or older.
The commercial launch of Sernivo Spray, a prescription topical steroid, is planned for the next quarter of this year.
The approval was based on two successful multi-centre, randomised, double-blind, vehicle-controlled clinical trials in these patients to evaluate the safety and efficacy of Sernivo Spray.
Dr Reddy’s Laboratories co-chairman and CEO G V Prasad said: "The FDA approval of Sernivo Spray is a significant milestone for Promius, as it validates our committed efforts and resources to developing differentiated dermatology products from concept to commercial launch.
"We are delighted to receive a first round FDA approval of Sernivo Spray as we look to expand our portfolio of medical dermatology products available in the US market."
In both trials, randomised subjects applied Sernivo Spray or vehicle spray to the affected areas twice daily for 28 days.
Enrolled subjects had a body surface area of involvement between 10% to 20%, and an Investigator Global Assessment (IGA) score of three (moderate).
Efficacy was assessed as the proportion of subjects who were considered a treatment, which was achieved in significantly more subjects using Sernivo than Vehicle at both Day 15 and Day 29 across both studies.
At Day 29 in trials 1 and 2, Sernivo achieved treatment success of 42.7% and 34.5% compared to vehicle success rates of 11.7% and 13.6%, respectively.
Promius Pharma president Raghav Chari said: "As an emerging leader in the dermatology space, we are committed to developing innovative treatment options and support services for clinicians and patients.
"The approval of Sernivo emphasises our ongoing efforts and we look forward to a successful launch of Sernivo Spray in the coming quarter."
Image: A person’s arm covered with plaque psoriasis. Photo: courtesy of Methoxyroxy.