FDA Questions Effectivness Of AstraZeneca Anticlotting Drug

26th Jul 2010 20:55

By Jennifer Corbett Dooren Of DOW JONES NEWSWIRES WASHINGTON (Dow Jones)--The Food and Drug Administration questioned the effectiveness of ticagrelor, a proposed anticlotting drug developed by AstraZeneca PLC (AZN, AZN.LN). 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. The drug faces a review Wednesday by the FDA's cardiovascular and renal drugs advisory committee. The panel of non-FDA medical experts is expected to vote on whether it thinks ticagrelor should be approved. The FDA posted a review of the product to its website Monday. 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). One of the main international clinical studies compared Brilinta to Plavix in 18,624 patients 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 by 16% compared with Plavix after being treated for a year. 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 because the aspirin dose was "generally higher" in the U.S. In a background document posted to FDA's website Monday, AstraZeneca said ticagrelor provides a "net benefit" over Plavix when looking at both safety and effectiveness measures. -By Jennifer Corbett Dooren, Dow Jones Newswires; 202-862-9294; [email protected] (END) Dow Jones Newswires July 26, 2010 15:55 ET (19:55 GMT)