The consumer group Public Citizen has urged the US Food and Drug Administration (FDA) to halt its review of, and reject, the platelet inhibitor prasugrel, a treatment for acute coronary syndrome (ACS) developed by Eli Lilly and Daiichi Sankyo.
Public Citizen and Victor Serebruany, one of the scientists who worked on early clinical studies of prasugrel, say the drug is neither safe nor effective. They also claim that the Phase III study, comparing prasugrel to Plavix (clopidogrel), contains serious flaws, such as incorrect and unsafe doses of prasugrel. According to Public Citizen, the high dose of prasugrel used in the study may be the reason for the ‘dramatic increase in the risk of haemorrhage and an unexpected increase in new cancers among patients on prasugrel when compared to those on clopidogrel’. They have urged the FDA to halt the current review until a new Phase III study can be conducted with a lower dose of the drug.
Kimberly Wix, director of public affairs at Daiichi Sankyo, points out that these concerns were heard by the FDA’s cardiovascular and renal drugs advisory committee, which went on to vote unanimously that prasugrel should be approved by the FDA. Daiichi Sankyo and Eli Lilly remain confident in the overall benefit-risk profile of prasugrel and stand behind the clinical trial design and results analysis, which ‘was rigorous and met the standards of regulatory authorities,’ says Wix.
Barbara Ryan, managing director at Deutsche Bank Securities, thinks that prasugrel will be approved. ‘Our sales estimate for 2013 is $1.2bn, so we do not see it replacing Plavix [an $8bn a year drug developed by sanofi-aventis and Bristol-Myers Squibb], but rather getting new patient starts in ACS,’ says Ryan.
Prasugrel is already approved in Europe.