The FDA has recommended that manufacturers developing new drugs and biologics for type 2 diabetes provide evidence that the therapy will not increase the risk of such cardiovascular (CV) events as a heart attack. The recommendation is part of a new guidance for industry that applies to all diabetes drugs currently under development.
“We need to better understand the safety of new anti-diabetic drugs. Therefore, companies should conduct a more thorough examination of their drugs’ cardiovascular risks during the product's development stage,” said Mary Parks, MD, director of the division of metabolism and endocrinology products for the FDA’s Center for Drug Evaluation and Research (CDER). “FDA's guidance outlines the agency's recommendations for doing such an assessment.”
The agency said that the guidance, which is effective immediately, defines more robust and adequate design and data collection approaches for phase 2 and phase 3 clinical trials than were previously required. Specifically, the guidance recommends that these studies demonstrate that new anti-diabetic therapies do not increase CV risk in comparison with existing therapies, especially when the drugs are used by patients of advanced age or by those with advanced diabetes or renal impairment.
The FDA also recommended that manufacturers have any CV events in their clinical trials analyzed by committees of outside cardiologists who are unaware of which patients received the tested products and which were on placebo. Based on these evaluations, the FDA can better ensure that product labeling includes information on safety and effectiveness, which will enable prescribers and patients to make better-informed decisions on the management of type 2 diabetes.
The agency said it remains confident that currently marketed anti-diabetic therapies are safe and effective when used according to approved labeling and advises patients to work with their healthcare professionals to select the most appropriate therapy to achieve adequate blood glucose control.
The FDA said it is continuing to evaluate how the recommendations will be applied to already approved anti-diabetic drugs and expects to release further guidance on this issue in the future.
“The FDA’s guidance and its ongoing evaluation of this issue supports our approach to drug regulation throughout the product life-cycle, by evaluating a drug's safety before and after its approval," said Janet Woodcock, M.D., director of the FDA’s CDER.