FDA panel unanimously recommends approval of Valeant’s brodalumab with conditions
pharmafile | July 20, 2016 | News story | Research and Development, Sales and Marketing | FDA, Valeant, brodalumab
Valeant has announced that the US Food and Drug Administration’s (FDA) dermatologic and ophthalmic drugs advisory committee has recommended brodalumab for the treatment of moderate-to-severe plaque psoriasis by a vote of 18 to 0.
Included with this recommendation, however, are several conditions related to product labelling and post-marketing/risk management obligations. The recommendation comes after FDA staff raised concerns over the data related to the drug’s possible suicide links.
Although not obliged to follow the committee’s recommendation, the FDA regularly follows it. They are set to make a decision on the monoclonal antibody, which targets the IL-17 receptor, on November 16th.
Valeant CEO, Joseph Papa, says: “The positive recommendation by the FDA’s advisory committee represents an important milestone toward our goal of delivering brodalumab to patients who suffer from moderate-to-severe plaque psoriasis. Brodalumab has the potential to improve the lives of many patients suffering from this chronic, debilitating disease, and we greatly appreciated the opportunity to present our body of evidence to the panel.”
Dr Mark Lebwohl, chairman of the department of dermatology at Mount Sinai School of Medicine, comments: “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.”
Sean Murray
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