AstraZeneca's Brilinta can be given for more than one year, says US FDA
AstraZeneca has won an extension to US regulatory approval for its star blood thinning drug Brilinta to allow it to be given to patients for more than one year after a first heart attack.
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The new 60mg tablet, which has been approved by the Food and Drug Administration (FDA) for this use, is expected to be available in pharmacies by the end of September 2015.
After one year of receiving the recommended 90mg twice daily dose of Brilinta during the first year after the ACS event, patients can now be treated with the new 60mg tablet twice daily.
"We know that patients remain at risk beyond the first year after their heart attack," said Elisabeth Björk, AstraZeneca's head of cardiovascular and metabolic disease development. "Today's approval is an important milestone that underscores the role Brilinta can play in reducing the risk of a subsequent cardiovascular event for patients both in the acute setting and in the longer term."
With this expanded indication, the already-blockbuster drug is now approved to reduce the rate of cardiovascular death, myocardial infarction - also known as heart attack - and stroke in patients with acute coronary syndrome or a history of heart attacks.
The expanded approval by the FDA came under its Priority Review designation, which is granted to drugs the body decides have the potential to provide significant improvements in the treatment, prevention or diagnosis of a disease.