GlaxoSmithKline granted European approval for BPH drug Duodart

GlaxoSmithKline has been granted approval under the European Decentralised Procedure for Duodart, its treatment for benign prostatic hyperplasia (BPH).

The company’s new therapy, which consists of a fixed dose combination of dutasteride and tamsulosin, has been ratified following a strong performance in the recent CombAT clinical trial.

Results from this study show that GlaxoSmithKline’s treatment demonstrated superior efficacy to tamsulosin, the most frequently-prescribed treatment for this condition, while causing few unexpected adverse side effects.

Eddie Gray, president of pharmaceuticals for GlaxoSmithKline in Europe, said the treatment will bring benefits for patients suffering from a condition which can cause “uncertainty and anxiety”.

He added that the drug “reduces the impact of the bothersome symptoms of this common condition and the risk of potential complications and related surgery”.

Last month, the company agreed to contribute doses of pneumococcal illness vaccine to developing nations at a discounted rate as part of the Global Alliance for Vaccines and Immunisation.