FDA accepts sNDA for Brilinta (ticagrelor) for prevention of Artherothrombotic Events-AstraZeneca

The FDA has accepted a supplemental new drug application (sNDA) and granted Priority Review for Brilinta (ticagrelor) tablets, from AstraZeneca, for patients with a history of heart attack. The sNDA is based on the results of the PEGASUS-TIMI 54 study, a large-scale outcomes trial in more than 21,000 patients that investigated ticagrelor tablets plus low dose aspirin, compared to placebo plus low dose aspirin, for the chronic secondary prevention of atherothrombotic events in patients who had experienced a heart attack one to three years prior to study enrollment. The Prescription Drug User Fee Act goal date will be in the third quarter of 2015.

BRILINTA is not approved for secondary prevention of atherothrombotic events in patients with a history of heart attack beyond one year or for the prevention of cardiovascular events in patients with peripheral arterial disease, stroke, diabetes or atherosclerosis.

Comment: Merck's PAR-1 receptor antagonist Zontivity (vorapaxar) secured approval in 2014 for patients with a prior heart attack, based on TRA 2P, which randomized patients with a heart attack between two and 12 months. The hazard ratio on the primary endpoint versus placebo was 0.83, with GUSTO severe bleeding increased by 24%. Zontivity is given in combination with both aspirin and clopidogrel, as opposed to just DAPT (dual antiplatelet therapy with aspirin plus clopidogrel, Brilinta, or Effient), so there are possible concerns about bleeding risk.