(Reuters) - AstraZeneca Plc on Thursday said the U.S. Food and Drug Administration approved a new dose of its blood thinner Brilinta intended for longer-term use in patients with a history of heart attack or a condition known as acute coronary syndrome.
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 a heart attack.
The FDA move comes a week after European heart experts endorsed the longer use of Brilinta and similar blood clot preventers.
The expanded approval could help to significantly increase sales of the heart drug as patients would be taking it for considerably longer periods than they are now. It would also greatly increase the numbers of patients eligible for the medicine to include those who had a heart attack more than a year ago.
Growing Brilinta is a high priority for the British drugmaker, which has forecast that annual sales of the drug could reach $3.5 billion by 2023. Brilinta sales rose 23 percent to $144 million in the second quarter.
Large clinical studies have shown a clear benefit in reducing heart risk from use of dual blood thinners beyond the first year after an attack.
“We know that patients remain at risk beyond the first year after their heart attack,” Elisabeth Björk, AstraZeneca’s head of cardiovascular and metabolic diseases, said in a statement.
Patients with a history of heart attack can now be treated with 60 mg of Brilinta twice daily along with a daily maintenance dose of aspirin of 75 to 100 mg beyond that first year, the company said.
Reporting by Bill Berkrot in New York and Samantha Kareen Nair in Bengaluru; Editing by Maju Samuel, Bernard Orr