FDA’s Endocrinologic & Metabolic Drugs Advisory Committee

Executive Summary

Will review Merck's Proscar (finasteride) on Feb. 4 for the treatment of benign prostatic hypertrophy. Merck Chairman Roy Vagelos, MD, reported in November that Proscar would receive an early February advisory committee review ("The Pink Sheet" Nov. 11, T&G-2). On Feb. 3, the committee will be joined by "worldwide urological experts" to discuss "state-of-the-art efficacy endpoints to be used for testing drugs" for BPH. The issues to be discussed will include the effect of BPH on urodynamic parameters, efficacy criteria used in BPH trials, current BPH therapy, and "the potential for masking prostatic cancers during anti-BPH therapy." The Feb. 3-4 meeting will be held at NIH's Building One, Wilson Hall, beginning at 8:30 a.m. each day....