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Home Industry News GSK receives approval for Avodart

GSK receives approval for Avodart

23rd April 2008

GlaxoSmithKline (GSK) has announced that approval has been granted for its product Avodart (dutasteride) to be co-administered with tamsulosin to treat benign prostatic hyperplasia (BPH).

The European Mutual Recognition Procedure granted regulatory approval for the drug to be used in Sweden – acting as the member reference state – with further approvals expected in 26 other European nations in the coming months.

Based on two years of results obtained from the ongoing Combination of Avodart and Tamsulosin (CombAT) study, it has been found that the combined therapy offers “significantly superior” improvements in patients suffering from BPH when compared with treatments using dutasteride alone.

“For patients with BPH whose disease is worsening and whose symptoms are moderate to severe, the co-administration of Avodart and tamsulosin offers the benefits of both medicines and provides doctors with an effective treatment option,” stated Dr Alastair Benbow, GSK’s vice-president and European medical director.

According to Bupa, BPH is caused by an overgrowth of prostate cells, which can constrict the urethra and reduce the flow of urine. It is thought that the condition affects around one-third of men over the age of 50 and shares similar symptoms to those of prostate cancer.

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