FDA pushes off ticagrelor decision for three more months

The FDA has extended the time to complete its review of the new drug application (NDA) for ticagrelor (Brilinta, AstraZeneca) from Sept. 16 to Dec. 16.

The London-based AstraZeneca said it will “continue to work closely with the FDA to support the review of the ticagrelor NDA.”

Ticagrelor is currently under regulatory review in nine additional global territories, including the European Union, Canada and Brazil.

Ticagrelor (Brilinta/Brilique), an investigational oral antiplatelet treatment for acute coronary syndromes, is a direct-acting P2Y12 receptor antagonist in a chemical class called cyclo-pentyl-triazolo-pyrimidines.

Ticagrelor is a reversibly-binding oral ADP receptor antagonist. The PLATO (PLATelet inhibition and patient Outcomes) study found that ticagrelor decreased incidences of cardiovascular death, MI and stroke when compared with clopidogrel (Plavix, Bristol-Myers Squibb/Sanofi-Aventis).