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FDA declines approval of ticagrelor without additional information
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The FDA has issued a complete response letter to AstraZeneca that requests additional analyses of the PLATO data in response to the company’s New Drug Application for its P2Y12 inhibitor, ticagrelor. This comes after the Cardiovascular and Renal Drugs Advisory Committee voted 7-1 in July to recommend approval of the drug for the reduction of thrombotic events in patients with acute coronary syndromes.
According to a press release issued by AstraZeneca, the FDA requested only additional analyses of the data presented in the PLATO trial and did not request that additional studies be conducted as a prerequisite for approval. AstraZeneca will be evaluating the contents of the letter and will respond to the agency’s request for additional analyses of the PLATO data as soon as possible, the release stated.
“Our highest priority is to provide the requested PLATO analyses to the FDA and progress to completion of the Brilinta [ticagrelor] New Drug Approval review,” Martin Mackay, president of research and development at AstraZeneca, said in the release.
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