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US approval for AZ's Brilinta

The US Food and Drug Administration has approved AstraZeneca's revised marketing application for blood-thinning drug Brilinta

The US Food and Drug Administration (FDA) has approved AstraZeneca's (AZ) marketing application for blood-thinning drug Brilinta (ticagrelor) to reduce cardiovascular death and heart attack in patients with acute coronary syndromes (ACS).

Brilinta will carry a boxed warning explaining that daily aspirin doses above 100mg decrease effectiveness.

The decision follows a December 2010 ruling from the FDA that the drug could not be approved in its then form. The agency did not request additional studies at the time, but did ask AZ to conduct additional analyses of the data from the company's PLATO trial, comparing the drug to current treatment Plavix (Clopidogrel), before considering the drug for approval again.

"In clinical trials, Brilinta was more effective than Plavix in preventing heart attacks and death, but that advantage was seen with aspirin maintenance doses of 75 to 100mg once daily," said Dr Norman Stockbridge, director of the Division of Cardiovascular and Renal Products in the FDA's Centre for Drug Evaluation and Research.

Brilinta is approved with a Risk Evaluation and Mitigation Strategy (REMS) – a plan devised by the FDA to ensure the drug's benefits outweigh its risks, with AZ required to conduct educational outreach sessions with physicians.

21st July 2011

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