EU agency meets to weigh fate of Glaxo's Avandia
* Avandia seen more likely to be withdrawn in EU than U.S.
* Experts consider heart risks linked to diabetes drug
* European Medicines Agency verdict expected on Sept 23
* Decision binding on all EU member states
By Ben Hirschler
LONDON, Sept 20 (Reuters) - Healthcare regulators will decide this week whether GlaxoSmithKline's (GSK.L) controversial diabetes drug Avandia should stay on the market in Europe, following concerns about its links with heart attacks.
Some European government safety experts, including those in Britain, argue that the risks of Avandia outweigh its benefits and the medicine no longer has a place on the market.
As a result, the drug, once Glaxo's second-biggest seller, is now more likely to be withdrawn in Europe than the United States, where concerns about the drug were first raised, industry analysts believe.
The decision rests with a committee of experts drawn from various national authorities who started their latest monthly meeting at the headquarters of the European Medicines Agency (EMA) in London's docklands on Monday.
A announcement is expected on the afternoon of Sept. 23, at the end of the four-day meeting, an agency spokeswoman said.
Pressure has increased for the European watchdog to pull the drug after British regulators said two weeks ago they had requested it be removed from sale. [ID:nLDE6850I3]
Under European rules, national agencies such as Britain's Medicines and Healthcare products Regulatory Agency (MHRA) must comply with the European consensus, since Avandia was licensed centrally by the EU body in 2000.
"Once the committee has reached a verdict, even if it is by a majority, and it has been endorsed by the European Commission, then it is binding throughout Europe," the EMA spokeswoman said.
Annual sales of Avandia reached $3 billion in 2006, but after health concerns emerged in 2007 its sales plunged to $1.2 billion in 2009, or 2.7 percent of group sales, as many doctors switched to Takeda's (4502.T) rival drug, Actos.
Actos is now the subject of a separate U.S. safety review into a possible link to bladder cancer.[ID:nN17177928]
In the United States, health advisers recommended in July that Avandia be allowed to stay on the market but with additional warnings. The U.S. Food and Drug Administration is expected to make a final decision on Avandia shortly, and the agency usually follows recommendations from its advisory committees. [ID:nN14274445]
Glaxo argues that extensive research has shown Avandia, known generically as rosiglitazone, to be safe and effective when used according to the label. (Editing by Will Waterman)
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