Makers of new diabetes drugs or biologics with no cardiovascular safety signal during clinical trials should submit long-term cardiovascular trial results or provide other evidence to rule out an unacceptable level of cardiovascular risk, an FDA advisory committee says.
CDER’s Endocrinologic and Metabolic Drugs Advisory Committee voted 14–2 last week, with no abstentions, in favor of the requirement. Panel members said such a long-term study would need to last five years and could be under way at the time the drug is approved.
The vote followed discussions of the cardiovascular adverse events associated with GlaxoSmithKline’s (GSK) Avandia (rosiglitazone maleate), a Type 2 diabetes treatment whose sales plummeted amid safety concerns and charges that the company did not disclose postmarketing data pointing to the problem.
Even a trial of five years may not catch all long-term benefits or risks of diabetes drugs, but it “seems like a reasonable, practical duration for the trial,” Saul Genuth of Case Western Reserve University, a nonvoting member of the advisory committee, said.
“I would want a new drug to be better than any current drug at lowering glucose. I still believe there is an independent cardiovascular benefit from lowering glucose, even though there may not be evidence yet from previous trials that may have been flawed in their design,” he said.Other members disagreed. A new cardiovascular study requirement for diabetes drugs could result in an unacceptable delay in the approval of new drugs, Eric Felner of Emory University School of Medicine’s Department of Pediatrics, Division of Endocrinology, said. He voted against the requirement.