FDA advisory committee recommends approval of brodalumab for psoriasis

The Dermatologic and Ophthalmic Drugs Advisory Committee appointed by the FDA has voted 18-0 to recommend approval of brodalumab injection, 210 mg, for treating adults with moderate-to-severe plaque psoriasis, according to Valeant Pharmaceuticals International.

“Brodalumab is an extraordinary drug that has meaningfully improved the quality of life of some of my most difficult-to-treat psoriasis patients, many of whom achieved complete skin clearance with this treatment,” Mark Lebwohl, MD, chairman of the Department of Dermatology, Mount Sinai School of Medicine, stated in a press release.

“I am very pleased that the advisory committee has recommended that this life-changing treatment should be available to psoriasis patients who require a treatment with brodalumab’s unique mechanism of action, and I look forward to prescribing this therapy to patients who are suffering from the devastating effects of moderate-to-severe plaque psoriasis.”

The committee’s recommendation, including conditions related to product labeling and post-marketing/risk, will be considered by the FDA as part of its review of the biologics license applications for brodalumab, a novel human monoclonal antibody that targets the interleukin-17 receptor. A Prescription Drug User Fee Act of Nov. 16, 2016, has been assigned by the agency, according to the release.

There have been reports of suicidal ideation and behavior with the product, according to the release.

“The positive recommendation by the FDA’s advisory committee represents and important milestone toward our goal of delivering brodalumab in patients who suffer from moderate-to-severe plaque psoriasis,” Joseph C. Papa, chairman and CEO of Valeant, stated in the release. “We greatly appreciated the opportunity to present our body of evidence to the panel. We look forward to working collaboratively with the FDA as it continues its review of the process.”

Arthralgia, fatigue, oropharyngeal pain and diarrhea were common adverse reactions reported with broadleaf, according to the release. There should be caution exercised when prescribing the product to patients with a history of Crohn’s disease, Valeant reported.

.Reference: www.valeant.com