GlaxoSmithKline has received a new indication for Avodart (dutasteride) in combination with the alpha blocker tamsulosin for the treatment of symptomatic enlarged prostate, a disease affecting half of all men over age 50.
This ruling reflects emerging research showing that the combination treats the condition’s symptoms more effectively than either medication alone.
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The approval was based on two-year results of the CombAT (Combination of Avodart and Tamsulosin) study of men with enlarged prostate, which showed that combination therapy with Avodart and tamsulosin was superior to both monotherapies at month 12 and continued to month 24.
Dutasteride and tamsulosin already had been approved for other indications related to enlarged prostate.
