GlaxoSmithKline has agreed to pay about $460 million to resolve a majority of lawsuits alleging the company's Avandia diabetes drug can cause heart attacks and strokes, people familiar with the accords said.
Glaxo, Britain's biggest drugmaker, agreed to settle about 10,000 suits for an average of at least $46,000 apiece, the people said. The company had been facing more than 13,000 suits alleging Glaxo hid the drug's heart-attack risk, according to a UBS AG analyst. The settlements come as Glaxo is set to face its first Avandia trial in federal court in Philadelphia in October.
Glaxo is settling Avandia claims as a U.S. Food and Drug Administration advisory panel met yesterday to consider whether the drug's ability to control blood-sugar levels outweighs a possible increase in heart attacks, strokes and deaths from cardiovascular disease.
Avandia generated $1.1 billion last year for Glaxo, only about a third of the revenue it had before researchers linked the medicine in 2007 to a 43 percent increased risk in heart attacks. Avandia was once the world's best-selling diabetes pill, generating $3 billion in annual revenue for Glaxo.
A former FDA official said Glaxo withheld from regulators a study showing Avandia may cause heart attacks, according to two people familiar with her deposition in a lawsuit against the drugmaker.
Dr. Rosemary Johann-Liang, a former manager in the FDA's drug-safety unit, told lawyers suing Glaxo that the 2001 study found Avandia posed a greater heart-attack risk than rival medicines. Glaxo also didn't turn over an e-mail from researchers who concluded Avandia "strengthens the signals" of heart ailments, she testified in a pretrial deposition last month, according to the people.
Glaxo disputes Johann-Liang's claims that it didn't turn over a 2001 review of Avandia's health risks to federal regulators, Mary Anne Rhyne, a company spokeswoman, said last week.