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Bausch Health, formerly known as Valeant Pharmaceuticals, said Thursday that it and its dermatology business, Ortho Dermatologics, received approval from the Food and Drug Administration for its DUOBRII lotion to treat plaque psoriasis.
The company halted trading pending the news. Its shares rose more than 3% after trading resumed.
"With today's approval of DUOBRII, patients suffering from plaque psoriasis now have an innovative topical treatment option that uniquely combines two well-known ingredients, halobetasol propionate and tazarotene, with established safety profiles, into a single lotion featuring dual mechanisms of action," Bill Humphries, president of Ortho Dermatologics, said in a statement.
The lotion uses a "unique" combination of halobetasol propionate and tazarotene, which are topical treatments used to treat skin disorders such as itching and swelling.
Plaque psoriasis is a chronic skin disease that causes skin cells to rapidly build on the surface of the skin, creating dry, red lesions. About 7.5 million people in the United States live with psoriasis, with about 80% of them having plaque psoriasis.
Bausch conducted two clinical trials, with 36% of patients in the first study and 45% in the second study seeing their skin clear up. The company said a majority of the patients maintained success in a four-week post-treatment period, giving patients "clear" or "almost clear" skin. It said the lotion treated superficial reddening of the skin and reduced scaling on lesions caused by the disease in these patients.
Topical steroids are normally used to treat psoriasis, but some of these creams can cause the skin to thin, also known as epidermal atrophy.
Correction: This story previously stated that the DUOBRII lotion had received tentative approval from the FDA in October. It was actually Bausch Health's BRYHALI lotion for plaque psoriasis that received tentative approval.