GlaxoSmithKline has grounds to celebrate this morning after a US joint advisory committee voted to allow the diabetes drug Avandia to remain on the market, although the label on the controversial treatment may be revised.

At the end of a two-day hearing of the US Food and Drug Administration’s Endocrinologic and Metabolic Drugs and the Drug Safety and Risk Management advisory committee looking primarily at the cardiovascular safety of the drug, twenty out of 33 panel members on Wednesday voted to recommend that the agency keep Avandia (rosiglitazone) on the market. 12 advisors voted to remove the diabetes drug's marketing authorisation and there was one abstention.

Of the panellists who backed Avandia, ten voted for additional warnings and restrictions on use, while seven recommended additional warnings only. Three said that no changes to the label were necessary. The committee also voted 19 to 11 that GSK's ongoing TIDE study assessing the cardiovascular risks of Avandia compared to Takeda’s Actos (pioglitazone) should continue.

GSK chief medical officer Ellen Strahlman said that following the recommendations, “we will, of course, continue to work with the FDA in the best interest of diabetes patients who face this chronic and serious disease”. She added that “we would like to acknowledge the efforts made by the FDA to apply scientific rigour to the debate and understanding of the benefit-risk profile of Avandia".

Analysts believe the result is certainly a good one for GSK but “Avandia is still not out of the woods yet,” said Tim Anderson at Sanford Bernstein & Co in a research note. He claimed the drug could still face withdrawal in other markets “but the odds seem better now with the US recommendation to stay on the market in hand.”

Emmanuel Papadakis at Collins Stewart was more upbeat, noting that “science wins the day following two days of confusion”. He said that the vote for additional warnings and restrictions on use of Avandia were largely anticipated and the recommendation to continue the TIDE trial should end “further debate on that topic”.

Most Avandia lawsuits settled
Just after the vote results were announced, GSK issued a statement saying that it expects to record a £1.57 billion charge in the second quarter which will include the settlement of “the substantial majority of the product liability cases relating to Avandia”.

The company did not specify how much was going to settle the Avandia lawsuits as the charge includes an investigation by the US Government into the company’s former manufacturing site at Cidra, Puerto Rico, as well as product liability and antitrust litigation relating to the antidepressant Paxil (paroxetine). The after-tax cost of the legal charge will be £1.35 billion.

Dan Troy, the company’s general counsel, said the charge “represents a substantial proportion of GSK’s outstanding litigation”. He added that this progress is helping us to reduce financial uncertainty and risk for shareholders”.

Collins Stewart’s Papadakis said the charge is in addition to existing £2.3 billion provisions, adding that “we view this clarity as a significant positive”.