The FDA has acknowledged the receipt of the AstraZeneca’s reply to the complete response letter for the ticagrelor (Brilinta) new drug application (NDA). The agency also set a new Prescription Drug User Fee Act date of July 20, at which time the agency is scheduled to make a decision on the approval or denial of the new antiplatelet agent.
Therefore, the agency has accepted AstraZeneca’s resubmission of the ticagrelor NDA, categorized it as a Class II resubmission to the complete response letter.
Ticagrelor, an oral antiplatelet treatment for acute coronary syndromes, is a direct-acting P2Y 12 receptor antagonist in a chemical class called cyclopentyltriazolopyrimidines. The drug is a reversibly-binding oral ADP receptor antagonist.
The FDA issued the complete response letter on Dec. 16, 2010. On Jan. 21, AstraZeneca announced it had submitted the requested supplementary analyses as part of its complete response letter. In September 2010, the Committee for Medicinal Products for Human Use approved ticagrelor in the European Union, where the drug is commercially sold as Brilique.
The London-based AstraZeneca said it “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.”