FDA Advisory Arm Recommends Brodalumab For Moderate-To-Severe Plaque Psoriasis


A US. Food and Drug Administration (FDA) advisory panel voted to greenlight Valeant’s IL-17 blocker brodalumab for the treatment of moderate-to-severe plaque psoriasis in adults.

The committee voted 18 to 0 in favor of brodalumab injection, 210 mg, for adults with moderate-to-severe plaque psoriasis, along with conditions related to product labeling and post-marketing/risk management obligations.

The FDA is not obligated to follow the advice of its advisory panels, but it usually does. The committee's recommendation will be considered by the FDA in its review of the Biologics License Applications for brodalumab. As previously announced, the FDA assigned a Prescription Drug User Fee Act action date of November 16, 2016.

"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," says Mark Lebwohl, MD, Chairman, Department of Dermatology, Mount Sinai School of Medicine in New York City, in a news 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." 

As previously announced, the Marketing Authorisation Application for brodalumab in psoriasis was accepted by the European Medicines Agency in Q42015. In August 2015, Valeant entered into a collaboration agreement with AstraZeneca granting Valeant an exclusive license to develop and commercialize brodalumab globally, except in Japan and certain other Asian countries where rights are held by Kyowa Hakko Kirin Co., Ltd. 

In July 2016, AstraZeneca and Valeant amended Valeant's license for brodalumab to terminate Valeant's right to develop and commercialize brodalumab in Europe.  LEO Pharma currently holds exclusive rights to develop and commercialize brodalumab in Europe, and Valeant holds the license to develop and commercialize brodalumab in the U.S and other territories, other than Japan and certain other Asian countries. In July 2016, brodalumab was granted approval from the Ministry of Health, Labour and Welfare Japan. 

The most common adverse reactions seen with brodalumab include headache, arthralgia, fatigue, oropharyngeal pain, and diarrhea. Caution should be exercised when prescribing to patients with a history of Crohn's disease.  Suicidal ideation and behavior have been reported.  The potential risks and benefits should be weighed before using brodalumab in patients with a history of depression and/or suicidal ideation or behavior. Serious infections have occurred. Caution should be exercised when considering the use of brodalumab in patients with a chronic infection or a history of recurrent infection. Patients should be evaluated for tuberculosis infection prior to initiating treatment.


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