FDA Wants Longer, Tougher Diabetes Drug Clinical Trials

WASHINGTON (Dow Jones) -- The Food and Drug Administration said Wednesday it's recommending more stringent clinical trials for diabetes drugs to better access heart attack and stroke risks more than a year after such safety questions were raised for GlaxoSmithKline PLC's (GSK) diabetes drug Avandia.

The move, outlined in an agency guidance document, is effective immediately and affects future drug applications as well as those currently pending FDA approval, including an application from Bristol-Myers Squibb Co. (BMY) and AstraZeneca (AZN) for saxagliptin, and one from Eli Lilly and Co. (LLY) and Amylin Pharmaceuticals Inc. (AMLN) for Byetta as a stand-alone treatment. It affects makers of type 2 diabetes drugs, or the more common form of the disease, and not makers of type 1 diabetes therapies.

Although FDA guidance documents are recommendations to companies and aren't binding, they have the effect of being a requirement as the agency can refuse to approve drugs that don't meet the recommendations.

Among the new criteria outlined is a recommendation that companies include older and sicker patients at higher risk of having a heart attack or stroke and that they be followed for up to two years rather than three-to-six months.

The agency said the studies should "demonstrate that new antidiabetic therapies do not increase cardiovascular risk in comparison with existing therapies." About 23 million Americans have type 2 diabetes, a disease characterized by high blood-glucose levels that result from the body's inability to use insulin. Diabetes also increases the risk of heart attacks and strokes, kidney and other health problems.

Companies also need to design clinical trials in such a way that they can be easy compared to access heart attack and stroke risks. The FDA also recommends that any cardiovascular events in their clinical trials be analyzed by an independent committee of cardiologists who are unaware of which patients received the test drugs and which ones were on placebo or a comparison treatment.

Mary Parks , FDA's director of metabolism and endocrinology products office, said previous guidelines required companies to conduct additional assessments of cardiovascular risks in situations where such a safety signal arose during the drug-development process. Now the assessment is being required for all type 2 diabetes drugs regardless of whether there's a signal.

She said the agency sent out more than 100 letters to companies with type 2 diabetes drugs in development informing them of the new guidelines.

While Parks said she couldn't comment specifically on pending drug applications, she said they would be looked at to determine if the new cardiovascular-risk guidelines are met. She said some companies may only have to make "very minimal" alterations to their new drug applications.

Novo Nordisk (NVO) has an application pending for liraglutide as a type 2 diabetes treatment and is expected to be discussed by an FDA advisory committee in early April.