London, October 10, 2002 - The U.S. Food and Drug Administration (FDA) today approved a supplemental new drug application (sNDA) for Dutasteride which is being marked under the brand name, Avodart®
The drug, manufactured by GlaxoSmithKline (GSK), is for the treatment of symptomatic benign prostatic hyperplasia (BPH) in men with an enlarged prostate. This new medicine for these patients will improve urinary symptoms, reduce risk of acute urinary retention (AUR) and reduce the risk of the need for BPH-related surgery.
Dutasteride, a second-generation 5 alpha-reductase inhibitor, is the first and only 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. Dutasteride's dual inhibition decreases levels of DHT by 90 percent at two weeks and 93 percent at two years.
By reducing DHT levels, dutasteride reduces the size of an enlarged prostate. This reduction in prostate volume was seen as early as one month with reductions continuing through treatment. Shrinking the enlarged prostate relieves urinary obstruction and improves urinary flow. Dutasteride also improves urinary symptoms and reduces the risk of AUR (the sudden complete inability to urinate) and BPH-related surgery, two potential long-term serious consequences of BPH. The pivotal phase III study data were published in this month's edition of the journal Urology.1
"With dutasteride, we now have a medicine that reduces the production of DHT by more than 90 percent, helping to shrink the prostate," said Claus Roehrborn, MD, a principal trial investigator and professor and chairman of the Department of Urology at the University of Texas Southwestern Medical Center in Dallas, Texas. "By taking dutasteride, patients can improve urinary symptoms and reduce their risk of suffering from acute urinary retention - where you suddenly can't urinate at all - or needing BPH-related prostate surgery."
Dutasteride was approved by the Swedish regulatory authority (MPA) on July 24th 2002. It will be marketed in Sweden by the trade name Avolve. The MPA agreed to act as the Reference Member State for the Mutual Recognition procedure within Europe and GSK plan to market the drug in all major European markets once approvals are finalised during 2003. The European trade name (Avolve) is to be confirmed.
According to Glaxo, Dutasteride will be available in pharmacies in December 2002.
