FDA Panel Splits on New Diabetes Drug
A U.S. Food and Drug Administration advisory panel has found that an experimental diabetes drug from Novo Nordisk does not appear to carry heart risks, but panel members were split on whether to recommend approval for the injectable medication because of its possible link to thyroid tumors.
The Danish drug maker has asked the FDA to approve liraglutide for millions of patients with type 2 diabetes. The drug has been shown to lower blood sugar levels while reducing weight, making it unique among diabetes medications.
According to the Associated Press, the panelists voted 6 to 6 on whether the drug should be approved, because research has shown it caused cancerous thyroid tumors in rats and mice. The panel voted 8 to 5 that liraglutide did not appear to hasten heart attack and other problems seen with similar drugs in recent years.
The FDA is not required to follow its advisory panels' advice, though it usually does.
Denmark-based Novo Nordisk is one of more than a dozen companies developing new therapies to compete in the $5.1 billion U.S. diabetes drug market, the wire service reported.
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