GlaxoSmithKline announced today that it has reached a $3 billion settlement agreement with the federal government, which had been investigating the company's marketing of its diabetes drug Avandia.

GSK announced back in January that it was taking a $3.5 billion charge to cover expenses linked to investigations and suits over Avandia.

The British company, which has its North American headquarters in Research Triangle Park, has set aside more than $6 billion for legal costs tied to the drug, which has been linked to increased risk of heart attacks.

European regulators ordered Avandia off the market more than a year ago, and the U.S. Food and Drug Administration restricted its use in the United States.
 

GlaxoSmithKline, the Triangle's largest drug maker, reported stronger first-quarter profit, even as sales continued to slow.

The British pharmaceutical company saw a steep drop in sales of pandemic flu vaccines and its controversial diabetes drug Avandia. Sales declines in the United States and Europe were offset by gains in emerging markets and Asia.

The results met or exceeded most analysts' expectations. Most analysts expect GSK sales to rise in the second half of the year.

"GSK is making good progress against our strategic priorities and we had a very positive start to the year," CEO Andrew Witty said on a conference call. "We are continuing to see good underlying sales growth momentum."

GlaxoSmithKline will take a fourth-quarter charge of $3.4 billion to cover various legal costs related to its controversial diabetes drug Avandia and other products.

The British company, which has its North American headquarters in Research Triangle Park, announced today that it will take the charge as it continues to settle lawsuits tied to Avandia, which has been linked to increase risk of heart attacks.

The charge also is tied to costs related to an investigation by the U.S. attorney in Colorado into the company’s U.S. sales and promotional practices of certain products.

GlaxoSmithKline reported a decline in third-quarter profit, hurt by weaker sales of its controversial diabetes drug Avandia and its pandemic flu vaccines.

The British drug maker also disclosed this morning that it is responding to a subpoena from the U.S. Department of Justice and several states' Attorneys General "relating to the development and marketing of Avandia."

"These enquiries are at an early-stage, and GSK is cooperating with these offices," the company wrote.

In September, GSK announced that it would stop promoting Avandia after European regulators ordered the drug pulled from the market and U.S. regulators required additional restrictions because of an increased risk of heart attacks.

In two major healthcare rulings today, European medical authorities suspended GlaxoSmithKline's Avandia while U.S. regulators said they will require stricter safety warnings for the diabetes drug that's packaged in Wake County.

The European Medicines Agency said Avandia will be phased out in Europe over the next several months and patients will need to find alternative treatments.

In this country, the Food and Drug Administration will require additional safety labels and restrictions on Avandia's use. The FDA adopted the July recommendation of a federal advisory panel, whose 33 members were deeply divided on the issue of the drug's safety.

Health authorities in Europe and the United States cited concerns about the increased risk of heart attack and stroke from using Avandia, once the world's leading diabetes medication that reaped $3 billion for London-based GSK in 2006.

GlaxoSmithKline's Avandia diabetes treatment should be withdrawn from the market, the British Medical Journal’s Editor-in-Chief Fiona Godlee wrote in an editorial published today, Bloomberg News reported.

The editorial comes as European regulators prepare to meet on the drug’s safety. The European Medicines Agency on Wednesday will discuss the “ongoing benefit-risk review” of Avandia, after research linked the drug to higher rates of heart disease.

Federal regulators have asked GlaxoSmithKline to stop enrolling new patients for a clinical trial of its controversial diabetes drug Avandia, while they review whether the drug should be pulled off the market.

Patients already enrolled in the so-called TIDE trial can continue to participate, but GSK announced today it will stop adding new patients.

In North Carolina, the only site participating in the TIDE trial is Duke University Medical Center, with Dr. Mark Feinglos as the principal investigator. Feinglos' office referred calls to a Duke spokesman, who wasn't immediately available.

GlaxoSmithKline said today it will spend a record amount of money on legal fees associated with lawsuits against its controversial diabetes drug, Avandia, and other issues.

The British company, whose North American headquarters is in Research Triangle Park, said it expects to record $2.36 billion in legal payments and fees in the second quarter.

The legal expenses are partly associated with settlements for Avandia, the onetime blockbuster diabetes drug that is associated with heart-attack risk. GSK did not provide specifics, but Bloomberg News reported this week that GSK has settled thousands of lawsuits against Avandia.

A federal regulatory panel today agreed that GlaxoSmithKline's controversial diabetes drug Avandia increases the risk of heart attacks and other cardiovascular problems.

But the panel also said that Avandia doesn't increase the risk of death compared with other treatments for the disease, Bloomberg News reported.

The advisers are considering in a series of votes whether available Avandia research is sufficient to determine the risk of the drug approved in 1999.

The panel is expected to recommend later today whether Avandia should be pulled from the market, slapped with stronger warnings or left alone. The FDA typically follows its panels' recommendations, but doesn't have to.

GSK officials say the drug is safe. The company wants to avoid the financial hit, legal hassle and PR headache that would come from withdrawing the drug.

A Food and Drug Administration commissioner said today that regulators considering a recall of GlaxoSmithKline's diabetes pill Avandia should "keep an open mind," Bloomberg News reports.

Margaret Hamburg made her comments during the first day of a two-day FDA advisory panel meeting on Avandia being held in suburban Washington.

"Follow the science, wherever it leads, and the rest will fall into place," Hamburg said.

Bloomberg also reported today that GSK has agreed to pay $450 million to settle a majority of the lawsuits, about 10,000, alleging Avandia can cause heart attacks and strokes.

At the conclusion of the two-day hearing, the panel is expected to recommend to the FDA whether the drug should be pulled or whether new warnings or restrictions are warranted because of safety concerns.