A U.S. Food and Drug Administration (FDA) advisory panel has voted 21-12 that the GlaxoSmithKline diabetes drug Avandia—once a blockbuster medication and now increasingly mired in controversy—should stay on the market, despite claims that it might promote heart attacks and strokes in some patients. At the same time, 10 of the FDA panelists called for limiting who can receive and who can prescribe the drug.
Although this is a win for GSK, compared to the huge financial hit it might take if the drug were pulled from the market, it still means challenges for the company moving forward, as it faced thousands of lawsuits and now the prospect of more limited sales of Avandia.
Market watchers are speculating that the FDA panel ruling may help GSK to fare better with the cases in the courts, but could also shrink Avandia sales to miniscule levels.
The FDA is not required to follow the advice of its panelists, though it usually does, and FDA officials have said they will, make a final decision about the drug soon.
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A U.S. Food and Drug Administration (FDA) advisory panel has voted 21-12 that the GlaxoSmithKline diabetes drug Avandia—once a blockbuster medication and now increasingly mired in controversy—should stay on the market, despite claims that it might promote heart attacks and strokes in some patients. At the same time, 10 of the FDA panelists called for limiting who can receive and who can prescribe the drug.
Although this is a win for GSK, compared to the huge financial hit it might take if the drug were pulled from the market, it still means challenges for the company moving forward, as it faced thousands of lawsuits and now the prospect of more limited sales of Avandia.
Market watchers are speculating that the FDA panel ruling may help GSK to fare better with the cases in the courts, but could also shrink Avandia sales to miniscule levels.
The FDA is not required to follow the advice of its panelists, though it usually does, and FDA officials have said they will, make a final decision about the drug soon.
There has been contradictory evidence both for and against the drug's value, and the advisory panel did earlier rule that the drug appears to increase heart attack risk, with FDA advisers voting 21-4 that Avandia is more likely to cause heartattack than its closest competitor Actos. Eight panelists maintained that not enough information existed to make such a determination. In the end, however, the panelists said the risks were not severe enough to justify removing a drug that hundreds of thousands of patient with diabetes rely on.
Following the July 14 advisory vote, GSK noted that committee members voted for recommendations ranging from making nochanges to the current label, to revising the label with additionalwarnings and restrictions to withdrawal from the U.S. market.
"Following today's recommendations, wewill, of course, continue to work with the FDA in the best interest ofdiabetes patients who face this chronic and serious disease," said Dr.Ellen Strahlman, GSK's chief medical officer. "Patientstaking Avandia should speak with their physician about their treatmentand any questions they may have regarding the safety of the medicine."
GSK notes that Avandia is "one of the most extensivelyresearched diabetes medicines and has been studied in more than 50,000patients," adding that the company has consistently shared data with the FDA andworked with the agency to update the label for Avandia as new databecame available.
GSK's view remains that controlledclinical trials are the most rigorous form of scientific evaluation that can be used to assess the benefits and risks of medicines. Resultsfrom six controlled clinical trials have been reported since the FDAlast reviewed questions about the cardiovascular safety of Avandia in2007. Together, these trials show that Avandia does not increase theoverall risk of heart attack, stroke or death, according to GSK, and "As a result, we believethat when used in the appropriate patient and in accordance withlabeling, Avandia is a safe and effective treatment option for type 2diabetes."
"Even if the FDA does not follow the panel's advice to withdraw or restrict prescribingof Avandia, physician and patient concerns about safety and litigation,and the availability of alternative therapies for most diabetics arelikely to lead to continuing decline in sales of Avandia," predicts Christine Henry, a healthcare analyst at Datamonitor. "Avandia's decline further opens the door forthe antidiabetics that have already filled the gap created after thefirst Avandia safety scare in 2007—class leader Actos as well as Merck's blockbuster DPP-4 drug Januvia (sitagliptin). With Avandia hitby safety fears and Actos approaching patent expiry in 2011, there isalso the possibility for newer drug classes to seize market share,maintaining the attractiveness of type 2 diabetes as a commercial andclinical target."
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