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FDA accepts priority review application for ticagrelor for patients with prior MI
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AstraZeneca announced that the FDA has accepted a supplemental new drug application and granted 6-month priority review for ticagrelor 60 mg and 90 mg for patients with prior MI.
Ticagrelor (Brilinta), an antiplatelet agent, is currently approved at a 90 mg dose to reduce the rate of thrombotic CV events in patients with ACS.
The new application is based on the results of the PEGASUS–TIMI 54 study, which were presented at the American College of Cardiology Scientific Sessions and published in the New England Journal of Medicine in March, according to a press release from AstraZeneca.
Results from the study of 21,162 patients with MI in the prior 1 to 3 years indicated that those assigned low-dose aspirin plus ticagrelor 90 mg or ticagrelor 60 mg had a lower risk for CV death, MI or stroke compared with those assigned low-dose aspirin plus placebo.
“There is a clear need for treatment options beyond the current standard of care of aspirin for the long-term prevention of atherothrombotic [CV] events in patients with a history of [MI],” Elisabeth Björk, MD, PhD, vice president, head of cardiovascular and metabolic diseases, global medicines development for AstraZeneca, said in the release. “Today’s milestone reinforces the importance of investigating clinical questions that address unmet patient need.”
As a result of the priority review designation, an approval decision is expected in the third quarter of 2015, according to the release.