GSK's Duodart receives approval in Europe

Published: 31 Mar 2010

GlaxoSmithKline's (GSK) two-in-one prostate drug Duodart has received approval in Europe. Duodart is the first fixed dose combination for prostate enlargement or benign prostatic hyperplasia (BPH) — an increasingly common problem for men as they age.

European approval was given via the Decentralised Procedure, with Germany acting as Reference Member State. The decision came 10 days after the drug received the green light in Switzerland, its first European market.

Duodart combines GSK's established drug Avodart (dutasteride) with Astellas Pharma's off-patent product Flomax (tamsulosin). In a four-year study the combination therapy was found to be more effective than monotherapy in improving symptoms and clinical outcomes in men with moderate-to-severe symptomatic BPH.

Said Eddie Gray, president, Pharmaceuticals Europe, GSK: "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 with 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. These are the factors which create uncertainty and anxiety for many men and may also lead to additional unplanned costs for healthcare providers."

Published: 31 Mar 2010

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