June 20, 2008

FDA Approves GSK’s Combination Therapy for Treatment of Enlarged Prostate

GlaxoSmithKline has announced that the FDA has approved Avodart in combination with tamsulosin for the treatment of symptomatic enlarged prostate, a disease that is said to affect half of all men over 50 years old.

The FDA approval was based on two-year results of the CombAT study, one of the largest clinical trials to date of men with enlarged prostate. The CombAT study is the first long-term assessment of the combination of Avodart and an alpha-blocker, the company said.

The CombAT study results showed that combination therapy with Avodart and tamsulosin was superior to both monotherapies at month 12 and continued to month 24.

Avodart already had been approved by the FDA for the treatment of enlarged prostate to improve urinary symptoms, reduce the risk of acute urinary retention, and reduce the risk of prostate-related surgery. Tamsulosin, an alpha-blocker, also has been indicated for the treatment of the signs and symptoms of enlarged prostate.