Panel OKs Diabetes Drug

By JENNIFER CORBETT DOOREN

06 april 2009--A Food and Drug Administration panel Wednesday backed a proposed diabetes drug being developed by Bristol-Myers Squibb Co. and AstraZeneca PLC, saying the product doesn't appear to increase the risks of heart attacks and strokes.

The panel of outside medical experts was called on by the FDA to discuss whether data submitted in favor of the drug, saxagliptin, was enough to rule out an "unacceptable excess cardiovascular risk relative to competitors."

Specifically, the panel voted 10 to 2 on a question that asked if there was enough evidence to show saxagliptin didn't carry excess cardiovascular risk. The vote effectively amounts to a recommendation that the FDA approve the drug. The agency isn't bound by panel decisions, though it usually follows its panels' advice.

The FDA's heightened concern about cardiovascular side effects was prompted, in part, by a research paper published in 2007 linking GlaxoSmithKline PLC's widely used Avandia to an increased risk of heart attack. The agency toughened regulatory approval guidelines for type 2 diabetes drugs in December. Applications for saxagliptin, as well as Novo Nordisk A/S's liraglutide, were submitted before the new guidelines were issued.

But the agency still required the companies to conduct cardiovascular-risk assessment of both products. The agency then sought the advice of medical experts on its Endocrinologic and Metabolic Advisory Committee about whether the analysis was sufficient, given that clinical studies were completed before the agency changed its guidelines.

If approved, saxagliptin would be sold with the brand name Onglyza. The FDA could make a final decision by the end of the month.

While the FDA said it saw a low cardiovascular-event rate in clinical studies, it also said it appeared patients in the studies were at low risk of developing cardiovascular problems. The new FDA guidelines also recommend companies include sicker patients in clinical studies.

The panel unanimously said there weren't enough data in saxagliptin's studies on cardiovascular risk to rule out a post-marketing study if the product were to be approved.

Brian Daniels, Bristol's senior vice president of global development and medical affairs, said the companies are planning a "large outcomes" study that would be developed with input from the FDA and other health authorities.