The U.S. Food and Drug Administration (FDA) approved BYHALIA Lotion indicated for the topical treatment of plaque psoriasis in adult patients, announced Bausch Health Companies Inc.
Byhalia (halobetasol propionate) is a new potent to superpotent corticosteroid in a novel vehicle lotion with safety established for dosing up to eight weeks.
“We are proud of our efforts to make Bryhali Lotion available as quickly as possible following final approval by the FDA,” said Bill Humphries, president, Ortho Dermatologics. “In doing so, our customers and their patients now have a new topical treatment option that provides the efficacy of a high-potency steroid with tolerability and longer duration of use.”
The drug bagged the approval after findings of the data from 2 prospective, multicentered, randomized, double-blind clinical trials.
In Study 1 and Study 2, 37 percent and 38 percent of patients, respectively, treated with BRYHALI Lotion achieved treatment success (at least a two-grade improvement from baseline in Investigator’s Global Assessment (IGA) and an IGA score equating to “clear” or “almost clear”) at eight weeks, compared to eight percent and 12 percent of patients treated with vehicle.
Data from both trials showed that BRYHALI Lotion demonstrated significant treatment success over the vehicle as early as week two (Study 1) and week four (Study 2), which continued through 12 weeks (four weeks post-treatment).
The most common adverse reactions, occurring in ≥1 percent of subjects treated with BRYHALI Lotion through week eight, were upper respiratory tract infection (2 percent), application site dermatitis (1 percent) and hyperglycemia (1 percent).
“BRYHALI Lotion will help address an unmet need for many plaque psoriasis patients,” said Lawrence J. Green, M.D., a lead investigator on the BRYHALI Lotion Phase 3 studies and associate clinical professor of Dermatology at George Washington University School of Medicine in Washington, D.C. “Topical steroids are the most frequently used treatment for psoriasis, but come with an increased risk of adverse events and a duration of use limited to two to four weeks. With BRYHALI Lotion, I’m excited to offer my patients a topical steroid option that can be used for up to eight weeks without sacrificing tolerability, and with proven efficacy.”
Bryhali Lotion will be available in 60g and 100g tubes.
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. People with psoriasis are also reported to be at increased risk of developing other serious clinical conditions such as cardiovascular and other non-communicable diseases and to suffer substantial impairment of physical and psychological quality of life. Plaque psoriasis is the most common type of psoriasis.