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Lilly and Daiichi-Sankyo submit prasugrel NDA in US

Daiichi-Sankyo and Eli Lilly submit a new drug application for their oral platelet anti-aggregant prasugrel in the US

Japanese pharmaceutical company Daiichi-Sankyo (D-S) and US-headquartered Eli Lilly have submitted a new drug application (NDA) for their oral platelet anti-aggregant, Effient (prasugrel), in the US.

The application was widely anticipated, following publication of the results of the TRITON-TIMI 38 trial, which demonstrated prasugrel's superior efficacy over French pharmaceutical company Sanofi-Aventis's Plavix (clopidogrel). However, concerns remain over prasugrel's links to serious bleeding.

The companies have applied for an initial indication to treat patients with acute coronary syndrome (ACS) who are managed with percutaneous coronary intervention (PCI), including coronary stenting.

Even assuming that the NDA is viewed favourably, the small difference in all-causes death between prasugrel and clopidogrel means that the former will face a tough battle to take over clopidogrel's status as the industry gold standard.

The risk of non-coronary artery bypass grafting (non-CABG) bleeding in prasugrel-treated patients was 2.2 per cent, compared to just 1.7 per cent for patients treated with clopidogrel. Meanwhile, the rates of life-threatening bleeding amounted to 1.3 per cent for prasugrel and 0.8 per cent for clopidogrel.

In terms of death from cardiovascular causes, there was a two per cent risk for prasugrel-treated patients compared with a 2.2 per cent risk for clopidogrel-treated patients.

The overall results demonstrated that for every 1,000 patients treated with prasugrel as compared with clopidogrel, there were 22 fewer patients with heart attacks and five more non-CABG-related major bleeds.

If the NDA is viewed favourably, Effient will be in a position to challenge Plavix. However, the small difference in terms of all-cause death means that Effient will face a tough battle to replace Plavix as the industry-standard drug. Also, generic versions of clopidogrel are likely to appear from 2011, putting further pressure on Effient.

For the EU, D-S and Lilly plan to submit an NDA in Europe in Q1 FY07.

In November 2007, a Nikkei report revealed that D-S was expanding its US pharmaceutical business in a bid to generate sales of at least JPY 200bn (USD 1.8bn) in FY09. The revised sales figure was approximately double that for FY06, according to Nikkei.

7th January 2008

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