Pharmaprojects R&D Pipeline News Feed
US group speaks out against prasugrel
5 Jun 2009
A US consumer advocacy group has written to the FDA urging them to cease their review of Daiichi Sankyo and Eli Lilly's antithrombotic prasugrel. Their request is based on a study (TRITON-TIMI) in 13,608 acute coronary syndrome patients which demonstrated that prasugrel increased the risk of possibly fatal haemorrhage by half and fatal haemorrhage fourfold when compared to clopidogrel (BMS' Plavix). The study also saw an 'excess of new cancers', with the group suggesting that while not carcinogenic per se, prasugrel may act as a cancer promoter.
Daiichi and Lilly however, stated that they remain 'confident in the overall risk-benefit profile of prasugrel', that the group's concerns had already been addressed at an FDA meeting in February and that they hope to have it on the market soon. Prasugrel was approved in the EU in February under the trade name Efient, and is already available in Germany and the UK.
The TRITON-TIMI study also found that prasugrel reduced the relative risk for the composite endpoint of cardiovascular death, non-fatal heart attack or non-fatal stroke by 19% compared with clopidogrel. Prasugrel is a P2Y12 purinoreceptor antagonist, in the same class as clopidogrel, which saw sales of US$5.6 billion last year. It works by inhibiting platelet aggregation via the glycoprotein IIb/IIIa pathway.
