The FDA’s Cardiovascular and Renal Drugs Advisory Committee Wednesday recommended the FDA approve AstraZeneca's investigational drug ticagrelor (Brilinta) for the reduction of thrombotic events in patients with acute coronary syndromes.
In response to the two questions below, seven members of the committee voted ‘yes,’ one member voted ‘no’ and none abstained:
- Should ticagrelor be approved for reduction of thrombotic events in patients with non-STEMI and STEMI ACS intended to be managed by PCI?
- Should ticagrelor be approved for reduction of thrombotic events in patients with non-STEMI and STEMI ACS intended to be managed medically?
The review by committee was based on the results of the head-to-head patient outcomes study PLATO (A Study of PLATelet Inhibition and Patient Outcomes), which was designed to establish whether ticagrelor could improve cardiovascular outcomes in ACS patients, compared with clopidogrel (Plavix, Bristol-Myers Squibb/Sanofi-Aventis). The study was designed to reflect current clinical practice and included all major ACS patient types (STEMI and UA/NSTEMI), whether they underwent PCI, CABG or were medically managed, according to the London-based AstraZeneca, which sponsored the trial.
The FDA is not obligated to follow the recommendations of the committee, but typically does.
The company filed the regulatory submission for ticagrelor in November 2009. Ticagrelor is currently under regulatory review in nine territories globally, including the European Union, Canada and Brazil.