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FDA Committee Accepts Efficacy of Propecia For Male Pattern Hair Loss WEST POINT, PA -- November 14, 1997 -- The Dermatologic and Ophthalmic Drugs Advisory Committee of the U.S. Food and Drug Administration (FDA) agreed data presented demonstrated that Merck and Co., Inc.’s investigational oral treatment, Propecia (finasteride 1 mg) is efficacious in treating men with male pattern hair loss (androgenetic alopecia). The committee's actions are based on three clinical studies involving 1,879 men ages 18 to 41 who had mild to moderate, but not complete, hair loss. Two of the studies examined hair loss on the vertex -- or crown -- of the head and the other focused on frontal/mid-area hair loss. These studies, which lasted up to 24 months, demonstrated that treatment with Propecia prevented further hair thinning and increased hair growth significantly in the majority of men with male pattern hair loss. Patients noted that treatment with Propecia led to clinical results within three months of starting treatment and improvements continued over the 24-month time period. Propecia will not be indicated for use in women or children and will be contraindicated in women when they are or may be potentially be pregnant. By inhibiting the enzyme 5 alpha-reductase, Propecia halts the conversion of testosterone to dihydrotestosterone (DHT), a hormone that causes male pattern hair loss in men genetically-predisposed to the condition. If cleared for marketing by the FDA, Propecia would be the only oral product available that treats the underlying cause of male pattern hair loss. Merck submitted a New Drug Application for Propecia to the FDA on December 19, 1996. E-mail this page to a friend or colleague! To print, use this version