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FDA approves Sernivo Spray topical steroid for psoriasis

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The FDA has approved Sernivo Spray, 0.05%, a topical steroid for treating mild-to-moderate psoriasis in patients aged 18 years and older, according to a press release from Dr. Reddy’s Laboratories.

The approval of Sernivo Spray, 0.05% (betamethasone dipropionate) was granted to Promius Pharma LLC, Dr. Reddy’s U.S. subsidiary, according to the release. A commercial launch of the product is set for next quarter, according to the release.

“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,” G.V. Prasad,  co-chairman and CEO, Dr. Reddy’s Laboratories, stated in the release. “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 U.S. market.”

The approval was based on results of two multicenter, randomized, double-blind clinical trials in which the safety and efficacy of Sernivo Spray were evaluated in participants aged 18 years and older with moderate plaque psoriasis. Randomized participants applied Sernivo Spray or vehicle spray to the affected areas twice daily for 28 days in both trials.

The proportion of patients who were considered a treatment success, defined as having an investigator global assessment score of 0 or 1 (clear or almost clear) and at least a 2-scale reduction from baseline), was used to measure efficacy.

According to the release, significantly more patients in the Sernivo Spray arms of both studies experienced treatment success at both day 15 and day 29. In study 1, Sernivo Spray had a treatment success rate of 42.7% vs. 11.7% for the vehicle, and in study 2, the success rate of Sernivo was 34.5%, vs. 13.6% for the vehicle. (P < .001).

Common adverse reactions of (at least 1%) after 28 days of treatment with Sernivo Spray or placebo included application site reactions, including pruritus, burning and/or stinging, pain and atrophy, according to the release.

Reference: www.drreddys.com