AstraZeneca Gets Priority Review for Expanded Brilinta Use
The FDA has agreed to fast track its review of a new indication for AstraZeneca’s blood-thinning drug Brilinta, meaning the therapy could be available for patients with a history of heart attacks by the third quarter of 2015.
AZ’s platelet inhibitor was granted priority review following results of the PEGASUS-TMI 54 trial, which showed a significant decrease in heart attacks in at-risk patients taking Brilinta plus low-dose aspirin versus those taking low-dose aspirin and placebo.
The FDA grants priority review when drugs have the potential to provide significant improvements over available treatments.
Brilinta (ticagrelor) was approved in July 2011 to lower the risk of cardiovascular death and heart attack in patients suffering from acute coronary syndrome. The drug gained a second administration option last month when the FDA approved it for use crushed and taken with water or through nasogastric tubes in patients who can’t swallow.
If approved, the new indication could push Brilinta sales to $3.5 billion annually by 2023, AZ predicts. — Jessica Grinspan