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.
FDA scientists stressed that most drug studies are discontinued after showing findings similar to the rat and mice studies conducted with liraglutide.
"It is very rare for a drug that has caused tumors in two species, in both genders at clinically relevant exposures, to be approved," said FDA drug reviewer Karen Mahoney. Novo Nordisk argued that while their drug spurs tumor growth in rodent cells, there is no comparable reaction in humans. But that reasoning failed to convince a majority of panelists.
"I just don't think we have enough data to be reasonably confident of safety in humans for long-term use," said Dr. Peter Savage, of the U.S. National Institutes of Health.
Liraglutide is among the first to go before the FDA's panel of diabetes experts since the agency issued new safety guidelines for diabetes treatments last year. The more cautious stance followed a 2007 controversy surrounding figures suggesting GlaxoSmithKline's blockbuster pill Avandia increased the risk of heart attack.
Because Novo Nordisk conducted its tests before the FDA issued the new guidelines, it primarily studied the drug in otherwise healthy diabetes patients in their 50s, excluding patients with elevated heart risks, the wire service reported. The FDA now requires companies to study high-risk patients, including the elderly, to give a more complete picture of the drug's side effects.
If approved, Novo Nordisk plans to the market the drug under the name Victoza. A decision is expected in the coming weeks, according to the AP.