By JENNIFER CORBETT DOOREN
WASHINGTON -- The Food and Drug Administration on Friday said it is concerned about allowing expanded use of AstraZeneca PLC's Seroquel amid possible increased risks of heart problems.
Seroquel is currently approved to treat bipolar disorder and schizophrenia. It is second only to the heartburn medicine Nexium in generating revenue for AstaZeneca, with sales of $4.45 billion in 2008.
The company is seeking approval to sell an extended-release version of Seroquel to treat generalized anxiety disorder and major depression. It will undergo a review by an FDA panel of outside medical experts on April 8.
The FDA said discussion will focus on "concerns regarding exposing a greatly expanded population to a drug with known metabolic side effects and a possible risk of tardive dyskinesia," a neurologic disorder that can be caused by drug exposure.
In a recent interview with reporters, AstraZeneca Chief Executive David Brennan said clinical trials looking at Seroquel for the treatment of major depression and generalized anxiety disorder showed the product is effective. He said he thought the benefits of treating patients at the severe end of the spectrum for their respective disorders outweigh risks associated with Seroquel.
In background materials prepared for the panel meeting, the FDA said clinical studies showed Seroquel was effective at treating major depression and generalized anxiety disorder. However, the agency said there is "accumulating evidence" that the drug may have "substantial metabolic risk," such as weight gain and an impact on blood glucose and lipids that in turn can cause cardiovascular problems and diabetes.
Write to Jennifer Corbett Dooren at jennifer.corbett-dooren@dowjones.com
No comments:
Post a Comment