To print: Select File and then Print from your browser's menu --------------------------------------------------------------------------------------- Title: FDA Committee Accepts Efficacy of Propecia For Male Pattern Hair Loss URL: http://www.pslgroup.com/dg/45EC2.htm Doctor's Guide November 14, 1997
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. --------------------------------------------------------------------------------------------- Copyright © 1999 P\S\L Consulting Group Inc. All rights reserved. Republication or redistribution of P\S\L content is expressly prohibited without the prior written consent of P\S\L. P\S\L shall not be liable for any errors, omissions or delays in this content or any other content on its sites, newsletters or other publications, nor for any decisions or actions taken in reliance on such content. --------------------------------------------------------------------------------------------- This news story was printed from *Doctor's Guide to the Internet* located at http://www.docguide.com --------------------------------------------------------------------------------------- Return to News Story Page This site is maintained by webmaster@pslgroup.com Please contact us with any comments, problems or bugs. All contents Copyright (c) 1998 P\S\L Consulting Group Inc. All rights reserved.