BEIJING, Sept. 14 (Xinhuanet) -- An US Food and Drug Administration expert panel said in a preliminary report on Monday that Abbott Laboratories Inc. did not provide clear evidence of effectiveness for its experimental prostate cancer drug, Xinlay.
Studies of Xinlay, which some analysts say could be a blockbuster drug if it goes to market, also raised "serious cardiovascular safety issues," the FDA staff said in the report.
The agency also complained that the definition of the primary endpoint in the clinical trials continued to evolve even after patients were enrolled, and that a number of protocol violations were observed.
Abbott, in a separate summary on the FDA Web site, said "the weight of evidence suggests that (Xinlay) provides measurable clinical benefit with a manageable safety profile."
"It was very clear going into the meeting that the panel was predisposed against the drug," Phillip Nalbone, analyst for RBC Capital Markets, said after the vote. "From my perspective it was a disappointment. We felt there is a lot of evidence here that this drug can help a lot of men with prostate cancer."
Abbott said that it respects the committee's vote against recommending the drug for approval but still awaits the FDA's final decision. The company continues to study Xinlay in clinical trials, one of which is studying the drug in early stage prostate cancer patients. That study is expected to be complete in 2006.
Abbott shares fell 38 cents to $44.85 in afternoon trading on the New York Stock Exchange.Enditem
(Agencies)
|
