Edited Press Release
LONDON -(Dow Jones)- GlaxoSmithKline (GSK) said Friday that it has submitted a Marketing Authorisation Application (MAA) in Europe for DuodartR (dutasteride 500 micrograms and tamsulosin HCI 400 micrograms) for the treatment of men with moderate-to-severe symptoms of benign prostatic hyperplasia (BPH) and reduction in the risk of acute urinary retention (AUR) and surgery, in men with moderate-to-severe symptoms of BPH.
The application has been filed in 28 European countries via the Decentralised Procedure with Germany acting as Reference Member State, the company said.
This MAA file is based on positive two year results results from the Combination of AvodartR and Tamsulosin (CombAT) study, and studies showing bioequivalence between combination and fixed-dose combination.
CombAT is a randomised controlled trial in more than 4,800 patients, which showed that combination therapy with dutasteride and tamsulosin provided significantly superior and sustained improvements over two years in symptoms, peak urinary flow (Q)and BPH-related quality-of-lifemax versus either monotherapy, in men with moderate-to-severe BPH symptoms.
The safety profile associated with combination therapy over a two-year period was consistent with that reported for either monotherapy. Although treatment-related adverse events (AEs) (mainly sexually related) were more common with the fixed-dose combination, withdrawal rates due to AEs were low (.5%) across all treatment groups, Glaxo said.
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Publié le 19 Décembre 2008 Copyright © 2008 Dowjones