The U.S. Food and Drug Administration has recommended that companies manufacturing diabetes treatment drugs provide evidence that their products will not increase cardiovascular risks.
The recommendation applies to all diabetes drugs currently under development. Although the recommendation is not a mandate, it’s apparent that companies that fail to follow it will have a harder time obtaining FDA approval.
“We need to better understand the safety of new anti-diabetic drugs,” said Mary Parks, M.D., director of the FDA’s Division of Metabolism and Endocrinology Products, Center for Drug Evaluation and Research, in a prepared statement. “Therefore, companies should conduct a more thorough examination of their drugs’ cardiovascular risks during the product’s development stage.”
The recommendation calls for stricter test design and data collection in Phase II and Phase III clinical trials than the agency previously required. Manufacturers must show that new diabetes drugs do not increase cardiovascular risks such as heart attacks, compared to existing drugs. Drugmakers must pay special attention to patients who are old or have advanced diabetes or kidney problems.
Previously, the FDA’s main criterion for approving a diabetes drug was whether it lowered blood glucose levels.
The agency is also recommending that if a drug company encounters any cardiovascular events during a clinical trial, it have outside cardiologists analyze them. The cardiologists would not be told who is receiving an experimental drug and who is receiving a placebo.
The recommendation addresses concerns that no current diabetes drugs have been shown to reduce the risk of heart disease-a risk that is two to four times greater in people with diabetes. Because diabetes patients require life-long treatment, the FDA wants to know if their drug therapies add to that risk.
The practical effect of the recommendation is that it will take longer and cost more for companies to bring anti-diabetes drugs to market.
Drugmakers that are currently working on new diabetes drugs include Amylin Pharmaceutical, AstraZeneca, Bristol-Myers Squibb, Eli Lilly & Co., and GlaxoSmithKline. In the U.S. market, current drugs generate $6 billion in annual sales.