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The Return Of The Blockbuster? Stage Is Set For Prasugrel Approval

Executive Summary

FDA's handling of the advisory committee meeting for Lilly/Daiichi Sankyo's platelet inhibitor prasugrel is the first signal in some time that the agency is ready to approve a primary care drug to be used in large patient populations with relatively limited restrictions

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Effient Review Delayed More By Management Issues Than Clinical Disputes

In FDA’s review of Lilly/Daiichi Sankyo’s antiplatelet agent Effient (prasugrel) – a drug with broad potential use – it is notable that the approval was delayed not by unusual clinical questions, but rather by the agency’s efforts to be exceedingly thorough and scrupulous in the review.

Effient Review Delayed More By Management Issues Than Clinical Disputes

In FDA’s review of Lilly/Daiichi Sankyo’s antiplatelet agent Effient (prasugrel) – a drug with broad potential use – it is notable that the approval was delayed not by unusual clinical questions, but rather by the agency’s efforts to be exceedingly thorough and scrupulous in the review.

Public Citizen Seeks To Hold Up Lilly Prasugrel Review For Further Data

Public Citizen's decision to file a citizen petition June 3 asking FDA to halt its review of Lilly/Daiichi Sankyo's prasugrel suggests the watchdog group may believe the agency is on the verge of approving the platelet inhibitor

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