Research & Development
Bausch Health Companies Inc announces tentative US FDA NDA approval for BRYHALI Lotion, 0.01% to treat plaque psoriasis
9 October 2018 -

Health care company Bausch Health Companies Inc (NYSE:BHC)(TSX:BHC) and its Ortho Dermatologics dermatology business, on Monday jointly announced tentative US Food and Drug Administration (FDA) approval for the New Drug Application for BRYHALI Lotion, 0.01% for the topical treatment of plaque psoriasis in adult patients.

Psoriasis is an immune-mediated disease that speeds up the life cycle of skin cells, causing them to build up rapidly on the surface of the skin. The extra skin cells form raised, red, scaly patches that are itchy and sometimes painful. Plaque psoriasis is the most common type of psoriasis.

According to the companies, BRYHALI (halobetasol propionate) Lotion, 0.01% is a new potent to superpotent corticosteroid that contains 0.01% halobetasol propionate in a novel vehicle lotion. Topical steroids are the most frequently used treatment for psoriasis, but long-term use has been limited due to risks of adverse events.

In conjunction with the approval, BRYHALI Lotion was evaluated in two prospective, multicentre, randomised, double-blind clinical trials to determine its safety and efficacy. The trials were conducted in 430 subjects who were 18 years of age and older with moderate to severe plaque psoriasis. The data from both trials showed that the BRYHALI Lotion applied once daily for eight weeks was shown to be generally well-tolerated with no increase in epidermal atrophy, added the company.

However, the final US FDA approval for BRYHALI Lotion is pending the expiration of exclusivity for a related product, which is expected in early November 2018, upon which, the company plans to launch the lotion in November 2018.

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