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Lilly and Sankyo’s prasugrel “an alternative medicine” to reduce heart attack risk
Daiichi Sankyo’s global head of research and development has suggested that prasugrel, if approved, would provide both patients and physicians with an “alternative medicine that may further help reduce the risk of heart attacks”.
John Alexander’s comments arrive as the US Food and Drug Administration (FDA) announced that it had accepted and designated for priority review the New Drug Application for Eli Lilly and Daiichi Sankyo’s prasugrel.
Prasugrel is indicated for patients with acute coronary syndrome being managed with percutaneous coronary intervention.
The FDA has now set a Prescription Drug User Fee Act (PDUFA) goal date following its priority review announcement.
Subject to the PDUFA data, the FDA has to deal with 90 per cent of its priority applications within six months, with the body able to approve, reject or demand further discussion for each candidate.
Dr J Anthony Ware, Eli Lilly vice-president for cardiovascular/acute care, stated: “We are greatly pleased to learn that the FDA has determined the application meets its criteria for such a review, and we look forward to working with the agency as it continues its review process.”
Also this week, Eli Lilly welcomed a new member to its board of directors with the election of United Parcel Services chief executive officer Michael L Eskew.
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