FDA Panel Backs Proposed Diabetes Drug Saxagliptin
April 01 2009 - 3:48PM
Dow Jones News
A Food and Drug Administration panel Wednesday backed a proposed
diabetes drug being developed by Bristol-Myers Squibb Co. (BMY) and
AstraZeneca PLC (AZN), 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, and
effectively amounts to a recommendation that the FDA approve the
drug. The agency isn't bound by panel decisions but 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 (GSK) 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 (NVO) liraglutide, were
submitted before the new guidelines were issued.
But the agency still required the companies to conduct
cardiovascular risk assessment of both products and 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.
-By Jennifer Corbett Dooren, Dow Jones Newswires; 202-862-9294;
jennifer.corbett@dowjones.com