A new dose of blood thinner Brilinta by AstraZeneca Plc that is intended for longer-term use in patients with a history of heart attack or a condition known as acute coronary syndrome (ACS) has been approved by the U.S. Food and Drug Administration.
The FDA approved Brilinta tablets at a new 60 milligram dose that would be taken along with aspirin beyond a year after a heart attack. The drug, which is used to prevent blood clots that can cause heart attacks, strokes and deaths, had previously been approved at a higher dose for use during the first year after acute coronary syndrome.
For the first year following an ACS event Brilinta is recommended for administration as 90-mg doses, two times a day. After one year the dose can be reduced to 60 mg. The drug can be used alongside a daily dose of 75 to 100 mg aspirin for maximum effect.
The FDA move could help increase sales of the heart drug and the numbers of patients eligible for the medicine to include those who had a heart attack more than a year ago.
Brilinta interferes with platelet activation. Based on studies, Brilinta was found to be more effective than clopidogrel at least for the first year following ACS, making it the first oral antiplatelet approved by the FDA to beat clopidogrel in reducing cardiovascular deaths. Brilinta also minimizes stent thrombosis in those who received stenting to treat ACS.
"We know that patients remain at risk beyond the first year after their heart attack," said Elisabeth Bjork, AstraZeneca's head of cardiovascular and metabolic diseases.
Reports say that 60-mg Brilinta tablets will be made available in pharmacies by the end of September.