FDA says Avandia decision due in days
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NEW YORK (Reuters) - The U.S. Food and Drug Administration will announce its decision on GlaxoSmithKline Plc's (GSK.L) diabetes drug Avandia within days, its deputy commissioner said on Tuesday.
The FDA has been reviewing the drug's label since July, when an agency advisory panel voted 22-1 to keep Avandia on the market but with new warnings about its risks following a report in May linking it to increased heart attack risk.
"I hope this will be announced very soon," Janet Woodcock told the Reuters Health Summit in New York. Asked if that meant in the next few days, she said: "Yes."
Woodcock confirmed the FDA's internal Drug Safety Oversight Board had delivered a recommendation to her office but declined to reveal its contents.
The final decision is up to the FDA's drug review office.
Sen. Charles Grassley, the ranking Republican on the Senate Finance Committee, said two weeks ago that committee investigators had learned the oversight board had voted to keep Avandia on the market by a narrow 8-7 vote.
Most industry analysts expect Avandia to remain available in the world's biggest drugs market but with stronger safety warnings -- possibly including a so-called "black box" warning, the strongest given by the regulator.
Avandia, which sold 1.6 billion pounds ($3.3 billion) worldwide in 2006, already carries one FDA black box warning for another condition, heart failure -- when a weakened heart cannot pump blood effectively.
A warning for the risk of heart attack would be more serious.
But Glaxo Chief Executive Jean-Pierre Garnier told the Reuters Health Summit on Monday that a black box warning would not necessarily be a disaster for the British-based group's second biggest seller. The key would be the language used by the regulator to describe the risk, he said.
Sales of Avandia have plunged since May when an analysis was published in the New England Journal of Medicine that linked the medicine to a 43 percent increase in heart attack risk.
Avandia revenues in the United States fell 48 percent from the year-ago period in the three months to September 30, to the benefit of Takeda Pharmaceutical Co Ltd's (4502.T) rival drug Actos.
($1=.4833 Pound)
(For summit blog: summitnotebook.reuters.com/ )
(Editing by Phil Berlowitz)
