AstraZeneca suffers new Brilinta delay

17th Dec 2010 07:13

AstraZeneca has suffered another delay in getting US approval for its potential blockbuster blood-thinning drug Brilinta after the US Food and Drug Administration requested more information.The FDA issued AstraZeneca with a complete response letter requesting additional analysis of the data from a study of the effects of Brilinta (ticagrelor) on 18,600 patients in 43 countries compared with its main rival Plavix.The trial showed that Brilinta was more effective than market leader Plavix (clopidogrel), manufactured by Sanofi-Aventis and Bristol-Myers Squibb, in preventing heart attacks, strokes and other heart-related deaths, but had a much higher number of negative outcomes in US patients.Astra said it has not been asked to undertake additional studies, including clinical studies, as a prerequisite for approval of Brilinta and will respond to the data request as soon as possible. The company added it remains confident in the NDA submission for ticagrelor and in its ability to respond to the agency's questions. "Our highest priority is to provide the requested PLATO analyses to the FDA and progress to completion of the Brilinta NDA review," said Martin Mackay, President, Research & Development, AstraZeneca.Brilinta and Plavix work by stopping blood platelets from clumping together and forming life-threatening clots in arteries. Plavix is the second largest selling drug in the world, with global revenue of nearly $10bn last year.