Posted: 02-23-10 Categories:
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FDA: No new conclusions on Glaxo’s Avandia yet

WASHINGTON (Reuters) – The U.S. Food and Drug Administration is reviewing data on possible heart risks with GlaxoSmithKline Plc’s diabetes drug Avandia but has not reached any new conclusions, the agency said on Monday.

The FDA will hold a public meeting in July 2010 to discuss the risks and benefits of the drug, but said in the meantime doctors and patients should continue to use Avandia as directed.

“This work is ongoing and no new conclusions or recommendations about the use of rosiglitazone (Avandia) in the treatment of type 2 diabetes have been made at this time,” the FDA said, referring to the drug’s generic name.

Democratic Representative Rosa DeLauro, in a statement posted on her website, urged the FDA to “remove Avandia from the market until a truly independent, science-based advisory panel can evaluate the safety and effectiveness of the drug.”

“It is reprehensible that many people might have suffered heart attacks or heart failure as a result of taking this drug, especially if a safer alternative exists,” said DeLauro, who chairs an appropriations subcommittee that funds the FDA.

Avandia came back in the spotlight after two U.S. senators on Saturday released a report on the drug and internal FDA documents. The documents included a 2008 memo from two FDA drug safety reviewers who recommended pulling the drug from the U.S. market after they concluded it was more dangerous to the heart than the rival drug Actos by Takeda Pharmaceutical Co Ltd.

One of the reviewers, FDA critic David Graham, had argued to an advisory panel in 2007 that Avandia should no longer be sold. That panel voted 22-1 to recommend the drug remain on the market.

Glaxo shares fell 2.5 percent to close at $37.32 on the New York Stock Exchange on Monday. Analysts said new attacks on Avandia could add to litigation risks and help rival drugmakers.

Sales of Avandia topped $3 billion in 2006, but fell to $1.2 billion in 2009.

Glaxo said the scientific evidence did not establish that Avandia increased heart attack risks and added it had been open in providing information about the drug.

The company “stands behind the safety and efficacy of Avandia when used appropriately and according to its label and maintains that this is an important medicine for the treatment of type 2 diabetes,” Glaxo spokeswoman Mary Anne Rhyne said.

The FDA said on Monday it is reviewing data from a Glaxo-sponsored study known as Record, as well as other studies that look at the cardiovascular safety of Avandia. The FDA will present all of the safety data at a public advisory panel meeting in July.

The FDA decided in November 2007 Avandia should carry a warning saying a review of 42 studies associated the drug with an increased risk of a heart attack or chest pain compared with a placebo. But it said overall data were “inconclusive.”

“We don’t find that available information since that time has really changed the assessment,” Dr. Janet Woodcock, head of the FDA’s drugs center, said on a conference call with doctors on Monday.

Woodcock added, “We feel that it is time for a thorough re-evaluation of all the data of the drug as far as cardiovascular risk, and we are undertaking that right now.”

Results from Glaxo’s Record study, published in the Lancet medical journal in June 2009, showed Avandia did not increase overall heart risks compared with older diabetes drugs.

“We are neither accepting nor rejecting that conclusion. We are going to have to review in great detail the study data as well as audit the study to determine how robust these findings are,” Woodcock said.

Concerns about Avandia emerged in May 2007 when Cleveland Clinic researchers published a study saying there was a link between the drug and heart attacks.

Jeffrey Holford, an analyst at stockbroker Jefferies, said early loss of Avandia from the U.S. market in mid-2010 would cut 2010 and 2011 earnings estimates by less than 1 percent.

(Reporting by Lisa Richwine, Susan Heavey and Ben Hirschler; editing by Andre Grenon, Leslie Gevirtz and Bernard Orr)

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