UPDATE: FDA Panel Backs Use Of AstraZeneca Anticlotting Drug Brilinta

28th Jul 2010 22:34

(Updates with FDA decision deadline, company comments.) By Jennifer Corbett Dooren Of DOW JONES NEWSWIRES WASHINGTON (Dow Jones)--A U.S. Food and Drug Administration panel Wednesday backed the use of ticagrelor, a proposed anticlotting drug developed by AstraZeneca PLC (AZN, AZN.LN), despite concerns about U.S.-patient data from an international clinical study. The company is seeking FDA approval of the product to prevent heart attacks and other cardiovascular problems in patients diagnosed with acute coronary syndrome. The company has proposed a brand name of Brilinta. Brilinta was reviewed Wednesday by the FDA's cardiovascular and renal drugs advisory committee. The panel voted 7 to 1 in favor of two questions that asked whether the drug should be approved for use in patients undergoing a procedure known as PCI to open blocked arteries as well as patients being managed "medically," or not expected to undergo an invasive procedure. The FDA usually follows the advice of its panels but isn't required to. The agency is expected to make a final decision by Sept. 16. Howard Hutchinson, AstraZeneca's chief medical officer, said the company was "extremely pleased" with the panel outcome. Brilinta, like the market leader Plavix, is designed to keep blood platelets from sticking together in order to prevent blood clots that can lead to heart attacks and strokes. Plavix is marketed by Sanofi-Aventis SA (SNY, SAN.FR) and Bristol-Myers Squibb Co. (BMY) and was the second biggest selling drug globally last year behind Pfizer Inc.'s (PFE) Lipitor. The main international clinical study AstraZeneca submitted to the FDA in support of approval compared Brilinta with Plavix in 18,624 patients in 43 countries who were being treated for a blocked artery or heart attack. Broadly, the results showed ticagrelor reduced the combination of heart attacks, strokes and death from cardiovascular causes for patients, after being treated for a year, by 16% compared with Plavix. All patients received aspirin. But when looking only at U.S. patients, the FDA said those patients had "worse results" with ticagrelor. The FDA said part of the reason could have been that the aspirin dose was "generally higher" in U.S. portion of the study, which included 1,413 patients, or possibly because of differences in the overall level of care. "What's being offered here...is this drug isn't doing what it's supposed to do in the country it's being considered for approval," said Robert Temple, a director in FDA's drug evaluation office, who explained the agency is struggling with a decision on whether to approve ticagrelor. However, the chances of FDA approval increased sharply after the panel voted to support the product. Jonathan Fox, an AstraZeneca vice president of clinical development, encouraged FDA's panel to focus on the overall study results and not the U.S. subgroup. "We are confident in the [effectiveness] of ticagrelor when used with low-dose aspirin." Indeed, the panel struggled during the day-long meeting to explain the difference in the results between U.S. and non-U.S. patients. Many said they thought it could be because of differences in treatment among U.S. patients, partly dismissing the idea that the aspirin dose made a difference in the treatment effect. "I don't think we have enough data to make a judgment which is very definitive," said James Neaton, a biostatistics professor at the University of Minnesota. -By Jennifer Corbett Dooren, Dow Jones Newswires; 202-862-9294; [email protected] (END) Dow Jones Newswires July 28, 2010 17:34 ET (21:34 GMT)