FDA accepts Astra's Brilinta resubmission

4th Feb 2011 07:03

July 20 is the new red letter day for AstraZeneca's quest to get its blood thinning drug Brilinta (ticagrelor) accepted by the US Food and Drug Administration (FDA). The FDA had raised concerns last year about Astra's first submission on the grounds of disparities in test results on US patients compared to results elsewhere. On 21 January Astra responded to those claims, more or less ascribing the differences to luck or, alternatively, an interaction between high dose aspirin and ticragelor. That seems to have satisfied the FDA, which has accepted Astra's resubmission of a new drug application (NDA).The FDA has classified the resubmission as class 2, which means it goes into a six month review cycle, hence the 20 July deadline for the next stage of the review process under the Prescription Drug User Fee Act."AstraZeneca remains confident in the NDA submission for ticagrelor and will continue working with the FDA to progress towards completing the review of the NDA for ticagrelor," the company said.