GlaxoSmithKline Plc‘s Avandia, once the world’s best-selling diabetes drug, will be withdrawn in Europe and restricted in the U.S. after a three-year review of the medicine’s heart risks.
Glaxo said it will stop promoting the drug in all countries after the decisions announced today by the European Medicines Agency and the U.S. Food and Drug Administration. Regulators disagreed on the reliability of the data and whether potential risks could be contained. Glaxo’s American depository receipts fell the most in a month in New York trading.
Avandia’s sales have fallen by two-thirds since an analysis released in May 2007 tied it to a 43 percent increased risk in heart attacks. Glaxo said sales will be minimal after this year. The financial impact on Glaxo will also be limited because Avandia’s patent expires in 2012, said Eric Le Berrigaud, an analyst at Raymond James in Paris.
“We struggled with it, and colleagues in other jurisdictions struggled as well,” Hans-Georg Eichler, the EMA’s senior medical officer, said on a conference call with reporters. “There’s no single perfect tool to study this risk.”
In the U.S., the medicine will carry new warnings after a three-year battle that divided staff at the FDA. London-based Glaxo must add new cautions to Avandia’s prescribing information, the agency said today. The decision to allow continued sales of the treatment follows the recommendations of an FDA advisory panel in July.
Heart Attack Risk
The FDA advisers called for stronger warnings on the label after re-examining a 2007 decision to keep the medicine on the market. Glaxo has said “extensive clinical data” have shown the treatment to be safe.
“Ninety-nine percent of drug use should go away,” Steven Nissen, chairman of the Cleveland Clinic’s department of cardiovascular medicine and author of the 2007 analysis, said in a telephone interview. “The drug will essentially disappear from use in the U.S. and will disappear in Europe.”
Glaxo’s ADRs fell 72 cents, or 1.8 percent, to $39.43 at 4:01 p.m. in New York Stock Exchange composite trading, their biggest percentage decline since Aug. 24. Each receipt represents two ordinary shares.
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Increased Danger
“Data from clinical trials, observational studies and meta-analyses of existing studies that have become available over the last three years have suggested a possibly increased risk of ischaemic heart disease associated with the use of rosiglitazone,” the EMA said today.
A study published last month found that Actos, which is the same type of treatment as Avandia, causes as many heart problems as the Glaxo medicine. Takeda says the drug is safe. Eric Abadie, the chairman of the EMA’s Committee for Medicinal Products for Human Use, said on a conference call that Actos doesn’t appear to have the same risks as Avandia.
FDA reviewers were divided about the Record study, according to documents released on July 9. Thomas A. Marciniak, a medical team leader at the agency, said Record “was inadequately designed and conducted,” while Ellis Unger, deputy director of the FDA’s Office of Drug Evaluation, called the results of the study “reassuring.”
Considerable Uncertainty
“We are not withdrawing the drug at this time because there is considerable uncertainty about this signal and whether it is valid,” said Janet Woodcock, head of the FDA’s Center for Drug Evaluation and Research, on a conference call today with reporters. The next step is for independent doctors to review Glaxo’s Record study.
The FDA ordered Glaxo to develop a program where doctors will register patients who are prescribed Avandia and document why they need the drug. Patients will have to review statements describing the cardiovascular safety findings and acknowledge that they understand the risks. Physicians will have to prove that people prescribed Avandia for the first time haven’t been helped by other diabetes drugs and choose not to take Actos because of medical reasons.
The new risk-management program will take “several months” to implement, the FDA said.
Warring Factions
“This is clearly a compromise between warring factions in the FDA,” said Diana Zuckerman, director of the National Research Center for Women & Families in Washington, whose father had taken Avandia. “For FDA to say they can manage this restriction seems overly optimistic, not evidence-based.” […]
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