Astra responds to FDA's BRILINTA concerns

21st Jan 2011 07:16

AstraZeneca has thrown the ball back in to the US Food and Drug Administration's court regarding the drugs giant's new drug application (NDA) for its blood thinning drug, BRILINTA.The Food and Drug Administration (FDA) issued Astra with a complete response letter (CRL) in December 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 "PLATO" 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.Having completed supplementary analyses of the trial, Astra believes that the apparent difference in treatment effect observed in the US and non-US patient subsets in PLATO is most likely a reflection of an underlying interaction between ticagrelor (BRILINTA) and higher doses of aspirin.The company continues to hold the view that either dumb luck or an interaction between high dose aspirin and ticagrelor are viable explanations for the efficacy differences observed in a subset of US patients in the PLATO trial.The CRL did not request that additional studies, including clinical studies, be conducted as a prerequisite for approval of the ticagrelor NDA. The FDA will now review AstraZeneca's response to determine whether the information submitted is complete and whether to move on to either a Class 1 two month review cycle or Class 2 six month review cycle.AstraZeneca remains confident in the NDA submission for ticagrelor and will continue to work with the FDA to progress towards the completion of the review of the NDA for ticagrelor.BRILINTA, Astra's oral heart treatment drug, is currently under regulatory review in 21 countries, including in the US. The product has been approved in 30 countries, including in the EU, Iceland, and Norway, under the trade name BRILIQUE and in Brazil under the trade name BRILINTA.