US regulator's panel declares Glaxo diabetes drug is safe
Thursday 15 July 2010
Glaxosmithkline's diabetes drug Avandia is safe enough to stay on the market, a panel of 33 medical experts decided last night at the conclusion of a contentious two-day hearing.
With hundreds of millions of dollars of sales hanging in the balance, an advisory panel to the US pharmaceuticals regulator said that Avandia did not appear to increase patients' risk of dying from a heart attack or stroke, as its critics argued.
The panel said the medicine ought to remain available on prescription in the US, the world's most lucrative pharmaceuticals market, if health warnings are strengthened on the drug's label.
The Food and Drug Administration, the regulator, convened the panel to get advice on what to do after a split within its own ranks over how to interpret mountains of scientific data, and amid pressure from politicians on Capitol Hill who argued that GSK was putting patients' lives in danger.
The British-based drug maker welcomed the decision. Its chief medical officer, Ellen Strahlman, said Avandia was one of the most extensively studied drug available to diabetes patients and it would work with the FDA to ensure its safe use. "GSK is dedicated to sharing data about its medicines transparently and in a timely manner. We remain fully committed to maintaining best practice disclosure of clinical data to serve the interests of regulators, physicians and patients."
The FDA does not have to follow the recommendations of its advisory panels, so it is still not certain that Avandia will remain on the US market, but the agency rarely diverges from the advice of independent scientists.
Avandia remains one of GSK's biggest selling medicines, despite a slump in sales since its safety was first questioned in 2007. It had sales of £169m in the first three months of this year. The company is facing thousands of lawsuits from patients and families of patients who say it caused them to have heart attacks or strokes, and the scientific evidence before the FDA panel was being closely watched by lawyers aiming to force GSK into expensive settlements.
The safety of Avandia in Europe is also up for discussion, and the European Medicines Agency will discuss the issue at its meeting in London next week.
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