Panel review date for prasugrel set for early February
Daiichi Sankyo and Eli Lilly have confirmed that the FDA’s Cardiovascular and Renal Drugs Advisory Committee (CRDAC) will review prasugrel during a committee hearing on Feb. 3.
In September 2008, the FDA failed to approve or disapprove the drug, and also failed to set forth any new timeline for approval. Then in December, the Committee for Medicinal Products for Human Use (CHMP) of the European Medicines Agency issued a “thumbs up” for prasugrel for the prevention of atherothrombotic events in patients with acute coronary syndromes being managed with PCI, according to the Indianapolis-based Lilly and the Toyko-based Daiichi.
“We welcome the opportunity to discuss any and all of the prasugrel data with the advisory committee and the agency, just as we have throughout the ongoing review,” said John Alexander MD, global head of research and development at Daiichi.
In September 2008, the FDA failed to approve or disapprove the drug, and also failed to set forth any new timeline for approval. Then in December, the Committee for Medicinal Products for Human Use (CHMP) of the European Medicines Agency issued a “thumbs up” for prasugrel for the prevention of atherothrombotic events in patients with acute coronary syndromes being managed with PCI, according to the Indianapolis-based Lilly and the Toyko-based Daiichi.
“We welcome the opportunity to discuss any and all of the prasugrel data with the advisory committee and the agency, just as we have throughout the ongoing review,” said John Alexander MD, global head of research and development at Daiichi.