 "Dr Reddy's US subsidiary gets USFDA nod for Psoriasis Spray product")
Promius Pharma LLC, a subsidiary of Dr Reddy’s Laboratories Limited, has received an approval from the US Food and Drug Administration (US FDA) for Sernivo (betamethasone dipropionate) Spray.
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, Dr Reddy's announced on Monday.
“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 of FDA approval of Sernivo Spray as we look at expand our portfolio of medical dermatology products available in the US market," said GV Prasad, co-chairman and CEO, Dr. Reddy’s Laboratories.
Raghav Chari, executive vice-president of Proprietary Products at Dr Reddy's and president of Promius Pharma 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."
Through its three business verticals-Pharmaceutical Services and Active Ingredients, Global Generics and Proprietary Products, Dr Reddy's offers a portfolio of products and services including APIs, custom pharmaceutical services, generics, biosimilars and differentiated formulations.
Promius conducted two successful multi-center, randomised, 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, randomised subjects applied Sernivo Spray or vehicle spray to the affected areas twice daily for 28 days.
Enrolled subjects had body survace area of involvement between 10% to 20% and an Investigator Global Assessment(IGA) score of 0 to 1(clear or almost clear) and at lest a 2- scale reduction from baseline), according to the company.
On day 29, in studies 1 and 2, Sernivo achieved treatment success of 42.7% and 34.5% compared to vehicle success rates off 11.7% and 13.6%, respectively, it said.