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FDA tentatively approves Bryhali lotion for plaque psoriasis
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Today, the FDA gave tentative approval to Bryhali lotion, 0.01%, for treating plaque psoriasis topically in adult patients, according to a press release.
“Our customers and their patients can benefit from this new treatment option that is expected to provide the efficacy of a high-potency steroid with tolerability and longer duration of use,” Bill Humphries, president of Ortho Dermatologics, said in the release.
The tentative approval is based on two prospective, multicenter, randomized, double-blind clinical trials that evaluated the safety and efficacy of Bryhali (halobetasol propionate, Bausch Health) lotion, 0.01%, among 430 patients aged 18 years and older with moderate to severe plaque psoriasis.
The trials demonstrated that about 38% of patients treated with halobetasol propionate achieved treatment success starting as early as week 2 and continued through 4 weeks post-treatment, compared with patients treated with vehicle, according to the release. Halobetasol propionate was also well tolerated, indicating no increase in epidermal atrophy over 8 weeks, according to the release.
The most common adverse events attributable to halobetasol propionate included upper respiratory tract infection (2%), application site dermatitis (1%) and hyperglycemia (1%), according to the release.
The final FDA approval of the novel once-daily corticosteroid lotion is pending the expiration of exclusivity for a related product and is expected as early as November 2018, according to the release.
“Topical steroids are a cornerstone of psoriasis treatment, but the efficacy of a high-potency steroid often comes with an increased risk of adverse events and a duration of use limited to 2 to 4 weeks,” Lawrence J. Green, MD, associate clinical professor of dermatology at George Washington University School of Medicine in Washington, D.C., said in the release. “In clinical trials, Bryhali Lotion has demonstrated good local tolerability for up to 8 weeks of treatment without sacrificing efficacy, making it an important new treatment option for psoriasis patients.”
Disclosure: Healio Internal Medicine was unable to confirm relevant financial disclosures at the time of publication.