GSK receives European approval for Duodart prostate drug, expects national licenses this year

GSK receives EU approval for prostate drug

LONDON — Pharmaceutical company GlaxoSmithKline PLC said Wednesday it has received European approval for Duodart, a two-in-one drug for the treatment of the symptoms of an enlarged prostate.

The drug is a combination of dutasteride, currently marketed as Avodart, and tamsulosin, a generic drug marketed by Astellas Pharma as Flomax.

Glaxo received backing for the drug from Germany under the European Union’s decentralized approval procedure, meaning it is applicable across the 27-member bloc. The company said national licenses 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.

Duodart is a once-daily dose to treat the condition.

In December, Glaxo withdrew its application to U.S. 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 percent.

Shares in Glaxo, the world’s No. 2 drug maker, were 0.3 percent lower at 1,260 pence in morning trade on the London Stock Exchange.