Shares of AstraZeneca inched up after the FDA released some generally positive reviews about Brilinta, the experimental blood thinner that goes before an FDA advisory committee tomorrow. The consensus view was that the therapy is approvable provided the agency requires a post-approval efficacy study once it hits the market.
Reuters highlights the remarks of one FDA reviewer who is skeptical about AZ's explanation for a lack of efficacy data among the small group of Americans included in the 18,000 people studied in an international clinical trial. Researchers for the company postulated that a higher level of aspirin dosing in the U.S. could explain why Americans didn't respond as well as others outside the U.S., where there was a significant reduction in deaths and heart attacks. But the reviewer, Thomas Marciniak, wasn't buying it. Marciniak was also troubled by the lack of follow-up data on patients. "One relevant question, given the incompleteness of follow-up, are the results real?" he asks.
Other staffers, though, were clearly impressed with the efficacy data recorded in a large number of subjects outside the U.S. And analysts in turn were quick to key in on the overall supportive tone of the agency review.
"The documents read more favorably in support of approval than we had expected," wrote Brian Bourdot, an analyst with Barclays Capital. And with the market-leading Plavix losing patent protection in 2011, Bourdot projects peak sales of $4 billion. After the surprising panel vote against the weight drug Qnexa, though, the only thing certain about tomorrow's review panel vote is that nothing is certain.
- here's the Reuters story
- read the Bloomberg piece