The European Medicines Agency said it was asking GlaxoSmithKline (GSK.L) additional questions about its diabetes drug Avandia before giving a final verdict later this month on whether it should stay on the market.
The EMA -- the European body that originally licensed Avandia in 2000 -- held an extraordinary expert meeting to review the drug's safety on Wednesday and said it would finalise its review on Sept. 20 to 23 at its next scheduled meeting.
Pressure has increased for the watchdog to pull the drug, which has been linked to heart risks, after British regulators said on Monday the risks from taking it were greater than the benefits. [ID:nLDE6850I3]
The EU agency said it had identified a number of unspecified questions it was putting to Glaxo that would help it decide whether marketing authorisation "should be maintained, changed, suspended or revoked."
Avandia used to be Glaxo's second-biggest drug, with sales of $3 billion in 2006 until health concerns emerged in 2007. Its sales plunged to $1.2 billion in 2009, or some 2.7 percent of group sales, as many doctors switched to Takeda's (4502.T) rival drug, Actos.
Glaxo said an extensive research programme showed Avandia was safe and effective when used according to label.
In the United States, health advisers recommended to regulators on July 14 that Avandia be allowed to stay on the market but with additional warnings. [ID:nN14274445]
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.
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