As Avandia regulatory fate looms, firm predicts sales drop

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Drug sales of rosiglitazone (Avandia, GlaxoSmithKline) will most likely decrease despite a majority vote by FDA advisers July 15 to keep the drug on the U.S. market, albeit, with potential added warnings or restrictions, according to market research firm Datamonitor.

At the meeting of the FDA's Endocrinologic and Metabolic Drugs Advisory Committee and Drug Safety and Risk Management Advisory Committee last Wednesday and Thursday, some members said that a “one-size-fits-all approach” to the drug should not be used because certain diabetic patients tolerate some antidiabetic drugs better than others; however, the majority of advisory members felt that pioglitazone (Actos, Takeda) held the same glucose control benefit as Avandia, without the potential cardiovascular risks.

“In the absence of stronger evidence for risk, there may be an incentive to keep Avandia on the market to allow for wider clinician choice, a view expressed in panel discussions,” said Christine Henry, an analyst with Datamonitor.

Even if the FDA allows the drug to stay on the market, it is probable that GlaxoSmithKline will see a drop in sales due to enlarged patient safety concerns, said Henry.

"Avandia’s [potential] decline further opens the door for the antidiabetic drugs that have already filled the gap created after the first Avandia safety scare in 2007," Henry said.

The thiazolidinedione pioglitazone and Merck’s DPP-4 sitagliptin (Januvia) are likely alternatives.

Due to the concerns associated with Avandia and the impending patent expiration in 2011 of Actos, new drug classes may “seize market share, maintaining the attractiveness of type 2 diabetes as a commercial and clinical target,” Henry concluded.