Galderma Laboratories' topical, once-daily Epiduo Forte gel, a combination of adapalene and benzoyl peroxide, has won approval from the FDA for use in patients with acne vulgaris. The approval was granted based on data from a late-stage trial that showed the treatment yielded significant improvements in acne severity after 12 weeks, compared with a vehicle gel.
The FDA approved Galderma Laboratories' Epiduo gel, or adapalene, to treat acne in children 9 and older. The approval was based on a 12-week trial involving 285 pediatric patients. Adapalene previously had been cleared for use treating children 12 and older.
The FDA approved Stiefel's Sorilux, or calcipotriene, to treat adults with psoriasis of the scalp. The therapy is already approved for psoriasis of other body parts. "We believe this additional indication for Sorilux foam will help meet the needs of both patients and physicians," said Susan Learned, Stiefel's medicine-development head for dermatology research and development.