Europe's CHMP Backs Ticagrelor for Approval in ACS

September 27, 2010

September 24, 2010 (London, United Kingdom) — The antiplatelet agent ticagrelor (Brilique in Europe, Brilinta in the US, AstraZeneca) has cleared the penultimate hurdle on the road to European formularies by getting a positive approval recommendation for the treatment of acute coronary syndromes from the Committee for Medicinal Products for Human Use (CHMP), AstraZeneca announced today [1].

It's now up to the European Commission to act on the committee's counsel, one way or the other. A positive decision is expected.

The CHMP based its recommendation largely on the strength of the approximately 18 000-patient Platelet Inhibition and Patient Outcomes (PLATO) trial, which saw a hazard ratio 0.84 of (p<0.001) for the primary end point of cardiovascular-related death, MI, or stroke for ticagrelor compared with clopidogrel (Plavix, Bristol-Myers Squibb/Sanofi-Aventis), with both agents on top of low-dose aspirin. The risk reduction with ticagrelor appeared driven by lower MI and CV death rates. Bleeding complication rates were comparable with the two agents.

In July in the US, the FDA Cardiovascular and Renal Drugs Advisory Committee gave ticagrelor a positive recommendation for patients with acute coronary syndromes, including STEMI, treated medically or with PCI, as reported by heartwire . The agency's decision is expected by the end of this year.

Unlike clopidogrel, still the most widely used on-top-of-aspirin oral antiplatelet even after the advent of its fellow thienopyridine prasugrel (Effient, Lilly), ticagrelor is a direct-acting P2Y12-receptor antagonist in the cyclopentyl-triazolo-pyrimidine class. In another difference, it must be given twice daily, not once daily like clopidogrel.

Adding further to differences between the agents that could affect how they are used in the future, generic versions of clopidogrel are expected in 2011. And other potential competitors are in the pipeline, including cangrelor (the Medicines Company) and elinogrel (Portola Pharmaceuticals).