The U.S. FDA has approved a supplemental new drug application for dutasteride for the treatment of symptomatic benign prostatic hyperplasia (BPH) in men with an enlarged prostate to improve urinary symptoms, reduce risk of acute urinary retention (AUR) and reduce the risk of the need for BPH-related surgery.
The drug is a second-generation 5 alpha-reductase inhibitor and is the first medicine to inhibit both the type 1 and type 2 enzymes responsible for the conversion of testosterone to DHT (dihydrotestosterone), the primary cause of prostate growth
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