|FDA is becoming more contentious of the heart when approving diabetes drugs. Source: Aging Management|
Pharmaceutical companies that produce diabetes drugs or biologics with no cardiovascular (CV) safety signal during clinical trials should be required to submit long-term CV trial results, or provide other evidence to rule out an unacceptable level of CV risk, according to a recent ruling from an FDA panel.
The FDA’s Endocrinologic and Metabolic Drugs Advisory Committee, which falls under the Center for Drug Evaluation and Research, voted 14–2 last week, with no abstentions, in favor of the requirement. The 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 previously scheduled meeting discussed the adverse CV events associated with GlaxoSmithKline’s (GSK) Avandia (rosiglitazone maleate), a type 2 diabetes drug, whose sales plummeted after eight years on the market when new trials raised concerns about the CV risks. In April, the FDA accused GSK of failing to report negative clinical data on Avandia to U.S. regulators.
Even a trial of five years may not recognize all the long-term benefits or risks of diabetes drugs, but it “seems like a reasonable, practical duration for the trial,” said Saul Genuth of Case Western Reserve University in Cleveland, a nonvoting member of the advisory committee.
The panel did consider, but rejected, the concept that a diabetes drug should be required to show CV benefit.
New CV study requirements for diabetes drugs could result in long delays in the approval process of new drugs, said Eric Felner of Emory University School of Medicine in Atlanta, who voted against the new requirement.