WILMINGTON, Del.—AstraZeneca announced today that it hassecured approval from the U.S. Food and Drug Administration (FDA) for itsBRILINTA (ticagrelor) tablets, indicated for the reduction of the rate of heartattack (myocardial infarction) and cardiovascular death in adult patientssuffering from acute coronary syndrome (ACS), compared to clopidogrel.
BRILINTA is an oral antiplatelet medicine indicated toreduce the rate of thrombotic cardiovascular events in patients with ACS. Ithas been shown to reduce the rate of a combined endpoint of cardiovasculardeath, MI or stroke when compared to clopidogrel. In addition, BRILINTA reducesthe rate of stent thrombosis in patients treated with percutaneous coronaryintervention. The drug has been studied in ACS when combined with aspirin, andmaintenance doses of aspirin over 100mg proved to decrease BRILINTA'seffectiveness. BRILINTA's approval is based on data from the PLATO study, inwhich BRILINTA and clopidogrel were compared as treatments in 18,264 ACS patientsworldwide.
"The FDA approval of BRILINTA is good news for patients inthe United States and represents a significant milestone as we seek to helpensure ACS patients around the world have access to this innovative medicine,"said David Brennan, CEO of AstraZeneca, in a press release.
Side effects of the drug include bleeding—which, as with allantiplatelet agents, can be significant—and dyspnea, or a feeling ofbreathlessness. No statistical difference was found between patients treatedwith BRILINTA and those treated with clopidogrel in terms of total majorbleeding events in PLATO. However, non-coronary artery bypass graft (CABG)events, both major and minor, were more common with BRILINTA than withclopidogrel.
With the FDA approval of BRILINTA, the drug is approved in39 countries, under the name BRILINTA in Brazil, Australia and Canada, andunder the name BRILIQUE in the European Union. It is under regulatory review in45 other countries, including China, India and Russia. AstraZeneca's next step isto begin work with hospital formularies, protocol committees and government andmanaged-case reimbursement bodies to start providing BRILINTA to patients.Opening BRILINTA up to increasing numbers of ACS patients will be a key focusfor the company over the next year.
Over one million Americans are hospitalized with ACS eachyear, according to the American Heart Association, and current estimates arethat up to one in three patients could face a recurrent heart attack or deathwithin one year of their first cardiovascular event.
"With over one million people affected by ACS in the U.S.each year, the fact that physicians have a new and more effective treatmentoption than clopidogrel to help reduce the rate of heart attack andcardiovascular death in these patients is an important advance," said Brennan.
