Dr Reddy’s Lab gets USFDA approval to market `Sernivo’ spray for psoriasis
09 Feb 2016
Dr Reddy's on Monday announced that its US subsidiary, Promius Pharma, has received approval from the Food and Drugs Administration (FDA) for Sernivo Spray, which is used for treatment of the skin disease, psoriasis .
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, DRL stated in a release.
Psoriasis is an autoimmune disease characterised 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 has 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.
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.
''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,'' Raghav Chari, executive vice president of proprietary products at Dr Reddy's and president of Promius Pharma, said.
