Friday, September 10, 2004

Outcome of FDA Meeting About Exanta

The Associated Press reported this evening about today's FDA meeting (see yesterday's post: Forthcoming Meeting...):

FDA Panel Urges More Studies of Stroke Med
By THE ASSOCIATED PRESS (copyright)
Filed at 8:51 p.m. ET

WILMINGTON, Del. (AP) -- A U.S. advisory panel on Friday recommended against approving AstraZeneca's new stroke prevention medication, Exanta, citing concerns about the drug's effect on the liver.

An advisory panel of physicians, meeting in Bethesda, Md., advised the Food and Drug Administration that more long-term studies are needed to assess the drug's safety, The (Wilmington) News Journal reported.

The FDA usually follows the recommendations of its advisory panels. The agency is expected to announce a decision on Exanta next month.

At the hearing, AstraZeneca made its case for Exanta's approval to the panel. Hamish Cameron, a company vice president, told the panel that Exanta represents a "real advance'' in the prevention of strokes.

But Ruyi He, an FDA official, told the panel that clinical testing of Exanta raised concerns that the drug could cause severe liver damage. He also raised concerns that patients taking Exanta may have a higher risk of heart attack.

AstraZeneca executives have portrayed Exanta as an alternative to the widely prescribed drug warfarin. Both drugs are supposed to reduce the risk of stroke by preventing blood clots.

AstraZeneca closed down 66 cents, to $43.73, on the New York Stock Exchange. The panel's recommendations were announced after the close of trading.

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