Glaxo Seeks Delay of Avandia Trials So Settlement Talks May Continue

GlaxoSmithKline is asking a federal judge to delay trial dates in the remaining lawsuits over Avandia heart problems, indicating that the drug maker is attempting to reach an agreement to settle the Avandia cases with the plaintiffs. 

The motion to defer was filed by the company on September 8, with less than a month before the first federal Avandia trial is scheduled to begin. Glaxo, which has already reached Avandia settlements in about 10,000 of the 13,000 lawsuits filed against the company, says that going to trial could interrupt further negotiations.

The federal Avandia litigation has been consolidated into an MDL, or Multidistrict Litigation, for pretrial litigation in the U.S. District Court for the Eastern District of Pennsylvania. A status conference is scheduled for September 22, with the first Avandia trial currently set to begin on October 5.

GlaxoSmithKline has reportedly already agreed to pay $460 million to resolve those first 10,000 Avandia lawsuits. The settlements come as FDA considers whether to keep the diabetes drug on the market or to issue an Avandia recall. In July, an FDA advisory committee voted to recommend that the agency allow the drug to remain on the market, but with additional restrictions and warnings.

The European Medicines Agency is also considering an Avandia recall, and provided a list of questions this week to the drug maker on the safety of Avandia and why it should stay in circulation. The questions themselves were not disclosed publicly.

Avandia (rosiglitazone) was approved in the United States in 1998 to treat type 2 diabetes by helping control blood sugar levels. The drug has been used by millions of diabetics, but sales have plummeted in recent years as concerns have mounted about the risk of serious and potentially life-threatening heart risks with Avandia. Some experts estimate that Avandia has caused between 60,000 and 200,000 heart attacks and deaths due to cardiovascular problems in the U.S. from 1999 to 2006.

Earlier this year, a Senate report on Avandia accused GlaxoSmithKline of suppressing the risks of Avandia, and indicated that many within the FDA have been calling for a recall of Avandia. Following the release of the scathing report, the FDA announced that it is still reviewing safety data on the drug. The FDA is also considering whether to allow clinical testing that would seek to quantify the health risks of Avandia when compared to Takeda Pharmaceutical’s competing drug, Actos. Many have called the test unethical and FDA has put a temporary pause on enrollment, which is relying heavily on recruiting test subjects from third-world countries. India has already forbade recruiting for the clinical trials.