Tricagrelor Recommended for Approval by FDA Committee

 

July 29, 2010

July 29, 2010 – A new, highly anticipated antiplatelet drug was recommended yesterday for final approval by the U.S. Food and Drug Administration (FDA) Cardiovascular and Renal Drugs Advisory Committee. The drug may challenge the current standard therapy of clopidogrel.

The committee voted to recommend that the FDA approve ticagrelor (Brilinta) for the reduction of thrombotic events in patients with acute coronary syndromes (ACS). The panel reviewed data from the PLATO (A Study of PLATelet Inhibition and Patient Outcomes) study, an outcomes trial of more than 18,000 patients whose data showed ticagrelor was superior to clopidogrel (Plavix) in the long-term reduction of cardiovascular events. The FDA is expected to make an approval decision in September 2010.

The advisory committee voted 7-1 in favor of ticagrelor being approved for reduction of thrombotic events in patients with non-ST-elevation myocardial infarction (NSTEMI) and ST-elevation myocardial infarction (STEMI) acute coronary syndromes (ACS) intended to be managed by percutaneous coronary intervention (PCI). The committee also voted 7-1 to recommend ticagrelor be approved for reduction of thrombotic events in patients with NSTEMI and STEMI intended to be managed medically.

“We are pleased with the advisory committee’s recommendation to support the approval of ticagrelor. We look forward to continued discussions with the FDA as it evaluates the panel’s recommendation and completes its review of the NDA,” said Howard Hutchinson, M.D., chief medical officer, AstraZeneca.

AstraZeneca filed the regulatory submission for ticagrelor in the second half of 2009. The proposed trade name for ticagrelor in the United States is Brilinta, pending approval from the FDA. Ticagrelor is also currently under regulatory review in nine territories around the world, including the European Union, Canada and Brazil.

The FDA frequently convenes advisory committee meetings to obtain independent expert guidance and recommendations on clinical matters. While the FDA is not required to follow this guidance, the agency takes the advice into consideration when rendering its final decisions on pending applications and other public health matters.

The PLATO Study

PLATO was a large (18,624 patients in 43 countries) head-to-head patient outcomes study of ticagrelor versus clopidogrel, designed to establish whether ticagrelor could achieve clinically meaningful CV and safety end points in ACS patients, above and beyond those afforded by clopidogrel. PLATO was designed to reflect current clinical management of ACS patients and included and represented all types of ACS patients (STEMI, NSTEMI and UA) whether they underwent invasive procedures or were medically managed.

As presented to the FDA advisory committee, ticagrelor demonstrated a reduction of CV events (CV death, MI, stroke) over clopidogrel (Plavix/Iscover) (9.8 vs. 11.7 percent at 12 months; 16 percent RRR; 95 poercent CI, 0.77 to 0.92; p<0.001), without an increase in overall major bleeding (11.6 vs. 11.2 percent, p=0.43). Across the overall PLATO population, there was an 11 percent risk of major and minor bleeding.

Pharmacology

Ticagrelor is a direct-acting P2Y12 receptor antagonist in a chemical class called cyclo-pentyl-triazolo-pyrimidines (CPTPs). Ticagrelor is the first reversibly binding oral ADP receptor antagonist.

For more information: www.astrazeneca-us.com