I’ll have more later, but I wanted to get this 148 page PDF file of Merck’s background materials — made public this afternoon — out right away. Happy digging!
Here is the FDA meeting announcement:
. . . .On December 1, 2010, the committee will discuss supplemental New Drug Applications (sNDAs) 021319/024, trade name AVODART® (dutasteride) Soft Gelatin Capsules, manufactured by SmithKline Beecham Corporation d/b/a (doing business as) GlaxoSmithKline and 020180/034, trade name PROSCAR® (finasteride) tablets, manufactured by Merck & Co., Inc. The proposed indication (use) for AVODART (dutasteride) is for reduction in the risk of prostate cancer in men at increased risk of developing the disease. The population at increased risk of prostate cancer includes men with an elevated serum prostate-specific antigen (PSA) or men otherwise determined to be at increased risk based on other associated risk factors such as age, race, and family history. There is no proposed expansion of the indication for PROSCAR (finasteride); however, in light of the Prostate Cancer Prevention Trial (PCPT) which demonstrated a statistically significant reduction in the 7-year period prevalence of prostate cancer with finasteride (PROSCAR) treatment, and which reported an imbalance in high Gleason grade prostate cancers (indicating more aggressive cancers) in the finasteride treatment arm vs. placebo, the efficacy and safety of both products for use in prostate cancer risk reduction will be examined. . . .
Back later tonight — board meetings call — but there is a quite-sensible argument to be made that even if approved, this drug ought not be eligible for reimbursement — for this condition.