The Dermatologic and Ophthalmic Drugs Advisory Committee of the FDA voted 12-0 Friday in favor of recommending approval of a biologics license application for teprotumumab, an experimental human monoclonal antibody shown to dramatically reduce the most debilitating symptoms of Graves’ orbitopathy.
Committee members expressed concern before casting votes about the small patient population studied — fewer than 90 adults treated with infusions of teprotumumab (Horizon Therapeutics) have been enrolled in controlled clinical trials — and several adverse events reported, among them
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