Monday, July 26, 2010

AstraZeneca - Brilinta: FDA asks why | Reuters

* Lack of U.S. benefit unexplained - FDA staff

* FDA reviewer: hard to discount benefit outside U.S.

* Panel to review drug on Wednesday

* AstraZeneca shares gain nearly 4 pct in New York (New throughout with documents released)

WASHINGTON, July 26 (Reuters) - U.S. reviewers provided mixed views on AstraZeneca Plc's (AZN.L) experimental blood thinner Brilinta, documents released on Monday showed.

The company's main study of Brilinta was generally well-run but had incomplete follow-up rates, according to a memo from Dr. Thomas Marciniak, a U.S. Food and Drug Administration heart drug reviewer.

Marciniak also said "aspirin dosing does not explain the disparate results" between U.S. patients and other countries. In the company study, U.S. patients failed to see the benefits of patients overall.

In a separate memo, reviewers in the FDA's clinical pharmacology office said they recommended Brilinta's approval with a post-market study "aimed to reconcile the findings from U.S. region."

An FDA advisory panel will consider the drug on Wednesday.

AstraZeneca shares gained 3.9 percent on the New York Stock Exchange. (Reporting by Lisa Richwine; Editing by Tim Dobbyn)

 

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