FDA’s evaluation of AstraZeneca PLC’s platelet inhibitor Brilinta (ticagrelor) was tinged by the agency’s prior review experience with Eli Lilly & Co./Daiichi Sankyo Co. Ltd.’s competing P2Y12 antagonist Effient (prasugrel) for acute coronary syndromes.
Shades of the prasugrel regulatory experience peek through in various places of the ticagrelor review, agency documents show. Among the areas affected by the prasugrel experience are regulatory timelines and...
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