Ortho Dermatologics Receives Tentative FDA Approval for Bryhali for Plaque Psoriasis

Monday, October 08, 2018 | FDA Approval/Clearance , Psoriasis , Ortho Dermatologics


The FDA has provided tentative approval of the New Drug Application for Bryhali (halobetasol propionate) Lotion, 0.01%, for the topical treatment of plaque psoriasis in adult patients. Bryhali Lotion is a new potent to superpotent corticosteroid that contains 0.01 percent halobetasol propionate in a novel vehicle lotion. Its safety has been established in clinical trials with dosing for up to eight weeks with no increase in epidermal atrophy. The final FDA approval for Bryhali Lotion is pending the expiration of exclusivity for a related product, which is expected in early November 2018. The company plans to launch Bryhali shortly thereafter, as scheduled, in November 2018.

“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,” says Bill Humphries, president, Ortho Dermatologics. “Just as every psoriasis patient’s journey is different, so too are their treatment needs, which is why psoriasis is a key therapeutic focus for our business. We look forward to adding Bryhali Lotion to our growing psoriasis portfolio.”

In clinical trials, Bryhali Lotion was applied once daily for eight weeks and shown to be generally well-tolerated with no increase in epidermal atrophy.1
 
“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 two to four weeks,” says Lawrence J. Green, MD, associate clinical professor of Dermatology at George Washington University School of Medicine in Washington, D.C. “In clinical trials Bryhali Lotion has demonstrated good local tolerability for up to eight weeks of treatment without sacrificing efficacy, making it an important new treatment option for psoriasis patients."

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