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EU approves GSK’s prostate drug


GlaxoSmithKline has received European approval for a drug to treat the symptoms of enlarged prostates.

The pharmaceutical giant said two-in-one drug Duodart combines dutasteride, otherwise known as Avodart, and tamsulosin, otherwise known as Flomax.

GlaxoSmithKline received German support for Duodart under an EU approval scheme, which makes it applicable across the 27-member bloc.

National licences for the once-daily dose are expected to be granted throughout the year.

Prostate enlargement is an increasingly common condition for men as they age. Almost four in 10 men over the age of 65 have the condition, which occurs when there is an overgrowth of cells in the prostate gland, blocking the flow of urine.

In December, Glaxo withdrew its application to US regulators to use Avodart to prevent prostate cancer, saying it wanted to provide an update after its initial research showed the drug could reduce the risk of that cancer by about 25%.

Flomax is a generic drug marketed by Astellas Pharma.

Copyright Press Association 2010

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