GlaxoSmithKline (GSK) announced that Duodart, fixed dose combination (FDC) of dutasteride (0.5mg), and tamsulosin (0.4mg) has received approval in Europe via the Decentralised Procedure with Germany acting as Reference Member State. Duodart is indicated for the treatment of moderate-to-severe symptoms of Benign Prostatic Hyperplasia (BPH) and reduction in the risk of acute urinary retention (AUR) and surgery in patients with moderate-to-severe symptoms of BPH1.

"Recognising the benefits of these two medicines and the significant proven benefit of their dual use, GSK developed this new fixed dose combination medicine to provide patients and physicians a convenient, once daily treatment, which reduces the impact of the bothersome symptoms of this common condition, and the risk of potential complications and related surgery," said Eddie Gray, president, Pharmaceuticals Europe, GSK. "These are the factors which create uncertainty and anxiety for many men and may also lead to additional unplanned costs for healthcare providers."

The regulatory submission for dutasteride and tamsulosin FDC was based on data from the CombAT study.

CombAT showed that the combination of dutasteride and tamsulosin offers patients with moderate-to-severe symptoms of BPH.