FDA C'tee Raises Concerns Over Merck's Propecia

The Dermatologic and Ophthalmic Drugs Advisory Committee of the US Foodand Drug Administration has concluded that Merck & Co's oral therapy Propecia (finasteride 1mg), is effective in the treatment of male pattern hair loss. Efficacy has been shown in the group studies, said advisory panel chairman Joseph McGuire of Stanford University. Panel member James Kilpatrick Jr of the Medical College of Virginia added that he was very impressed by the effectiveness of the studies.

The panel, however, stopped short of recommending Propecia, which is a low-dose formulation of Merck's already-approved drug Proscar, used in the treatment of enlarged prostate glands, for approval, with members of the committee raising a number of concerns.

By inhibiting the enzyme 5 alpha-reductase, Propecia halts the conversion of testosterone to dihydrotestosterone, which causes male pattern hair loss in genetically predisposed men. Propecia reduces DHT concentrations in the scalp by around 60% and miniaturizes scalp hair follicles, resulting in a reversal of the balding process, according to the company.