Diabetes drug Avandia to stay on market

The benefits outweigh the risks so diabetes drug Avandia should remain on the market, a panel of U.S. advisers said Monday.

It was a mixed finding for Deerfield-based Takeda Pharmaceuticals North America Inc. Its diabetes pill, Actos, is in the same drug class, and the panel could have ruled against the entire thiazolidinediones class of pills, which work to increase a diabetes patient's sensitivity to insulin.

The panel of medical specialists also voted at a meeting in Gaithersburg, Md., that Avandia should receive new safety warnings. It found that Avandia increases the likelihood of heart attacks.

Data on Avandia "does suggest there is an increased risk," said Dr. Clifford Rosen, the panel's chairman.

The FDA often follows the advice of its advisory panels.

Shares of GlaxoSmithKline Plc, owner of the Avandia brand, saw shares rise 5.2 percent in extended U.S. trading to $52 from their close of $49.43.

After the finding, Takeda North America issued a statement distancing its Actos from Avandia.

Actos is the only thiazolidinedione with safety data from a cardiovascular outcomes trial in its label, the statement said.

"Although drugs may be in the same class, they also can have different clinical effects due to differences in molecular structure," said Dr. Mehmood Khan, president of Takeda Global Research & Development Center.

Avandia was the world's best-selling diabetes drug last year, with sales of $3.3 billion. Sales plummeted after a May New England Journal of Medicine report linked the medicine to a 43 percent increased risk of heart attacks. Other research conflicts with that study.

GlaxoSmithKline objected to part of Monday's finding, contending Avandia is safe.

"There is no overall evidence that (Avandia) is different from other oral anti-diabetic agents" with regard to heart attack risk, said Murray Stewart, GlaxoSmithKline vice president for clinical development.