Dr. Reddy’s announced on Monday that its US subsidiary, Promius PharmaTM, LLC, U.S. has received approval for Sernivo™ Spray, 0.05% from the U.S. Food and Drug Administration (FDA).
Sernivo—generically called betamethasone dipropionate—is a prescription topical steroid that is used to treat mild to moderate plaque psoriasis in patients who are 18 years and older.
Psoriasis is an autoimmune disease characterized by patches of abnormal skin that are itchy and scaly. There is no cure yet, but the symptoms can be controlled by application of steroid creams and other drugs.
The commercial launch of the product is planned for the coming quarter.
“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,” said co-chairman and CEO, Dr. Reddy’s Laboratories.
Promius had 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. At Day 29 in Studies 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 (p<0.001).
Sernivo is the third FDA approval for Dr Reddy’s in two weeks—the company got approvals for ZEMBRACE SymTouch or sumatriptan succinate injection for acute migraine in adults and a tentative approval for 40 mg Zenavod antibiotic capsules to treat rosacea, a skin condition.
Together, the company expects the three products to have potential sales of around $50-75 million in the near term. It already has four dermatology products in US which did sales of around $36 million in FY15.
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 emphasizes our ongoing efforts and we look forward to a successful launch of Sernivo Spray in the coming quarter.”
Source: Dr. Reddy’s