US May Raise Standards for Diabetes Drugs

Higher standards could force manufacturers to conduct longer and more expensive clinical trials.

"A requirement for demonstrating cardiovascular benefit will likely have major implications on the availability of new treatments for type 2 diabetes," Food and Drug Administration staff wrote in a summary prepared for an advisory panel that meets Tuesday and Wednesday.

"Establishing a hurdle of long-term, costly trials to exclude cardiovascular harm" also could impact drug development, particularly if applied to every product, the agency staff said.

Diabetes medicines are among the biggest sellers with new drugs from Merck & Co Inc, Eli Lilly and Co and others taking off in recent years. U.S. sales of the most widely used drugs topped $6 billion in 2007, according to healthcare information company IMS Health.

The issue of testing requirements carries "high public health importance" as diabetes is widespread and most diabetics die from heart disease, FDA staff said. U.S. government estimates show nearly 24 million Americans have diabetes. Most cases are type 2 diabetes, which experts link with obesity, poor diet and lack of exercise.

Companies currently need to show their drugs control blood sugar to win U.S. approval. Experts believe blood-sugar control helps prevent complications such as heart disease. But no "conclusive" evidence exists that any approved diabetes drug reduces cardiovascular risks, the FDA staff review said.

Calls for a tougher standard came last year when an analysis by Cleveland Clinic researchers found Glaxo's Avandia raised heart-attack risk.
Glaxo disputed the results, saying the drug's safety was comparable to similar pills, but agreed to add a strong warning that Avandia might increase the chances of a heart attack. Company studies of Avandia's cardiac effects are continuing.

The FDA will ask the advisory panel how much data officials should demand for already approved drugs and new ones. The agency usually follows panel recommendations.

The worst-case scenario for companies would be a requirement that all diabetes drugs have data on outcomes such as heart attacks prior to approval, But, it is more likely, that the FDA will mandate that type of study after approval, or apply it only to drugs that show some reason for concern during early development.

That may help medicines known as GLP-1 analogs or incretin mimetics. They include Novo Nordisk's experimental liraglutide and Amylin Pharmaceuticals Inc's Byetta, marketed with Lilly. A once-weekly version of Byetta is in development. Those drugs do not cause weight gain as some others do, which could help them escape higher standards.

Others that could face new requirements include a family called SGLT2 inhibitors. Companies developing those medicines include Glaxo, Bristol-Myers Squibb Co, AstraZeneca Plc, Sanofi-Aventis and Isis Pharmaceuticals. 

Still, this draft of questions to be considered at next week’s panel meeting suggests that the discussion could be pretty wide-ranging. The first question on the list gets to heart of the matter: “What specific cardiovascular assessments should be required as part of the approval process for drugs and biologics developed for the treatment of type 2 diabetes, and why?”

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