Prasugrel Outperforms Clopidogrel In Head-To-Head Test For Recurrent Events
This article was originally published in The Pink Sheet Daily
Executive Summary
Lilly and Daiichi Sankyo await Sept. 26 FDA action date for anti-platelet drug slated to take on Bristol’s Plavix.
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New Phase III data show prasugrel, Lilly and Daiichi Sankyo's investigational oral anti-platelet drug, outperforms clopidogrel in acute coronary syndrome patients managed with percutaneous coronary intervention. Such patients were 35 percent less likely to experience a recurrent cardiovascular event when receiving prasugrel as opposed to clopidogrel, Lilly announced Aug. 21. The new data from the Phase III TRITON-TIMI 38 study was published in the August edition of the European Heart Journal. Lilly and co-development partner Daiichi Sankyo filed an NDA for prasugrel in ACS last December. FDA's original action date of June 26 was moved back three months to Sept. 26 in June (1 (Also see "Prasugrel Delay Shifts Focus To Possible August Advisory Committee" - Pink Sheet, 24 Jun, 2008.)). For the trial, a recurrent event was defined as a heart attack, stroke or cardiovascular death. The randomized, double-blind, head-to-head trial enrolled 13,608 patients in 30 countries. Of those, 10.8 percent who received prasugrel, which will be marketed in the U.S. as Effient , suffered a recurrent event, compared with 15.4 percent who received clopidogrel (Bristol-Myers Squibb's Plavix ). Overall, there were 58 recurrent events within the prasugrel group, compared with 115 in the clopidogrel group. The recurrence of subsequent events assessment was part of the larger TRITON-TIMI 38 study, whose primary finding was that prasugrel with aspirin reduced the relative risk of a combined endpoint of cardiovascular death, non-fatal heart attack or non-fatal stroke by 19 percent compared with clopidogrel and aspirin (2 (Also see "Prasugrel: To Be (Approved) Or Not To Be" - Pink Sheet, 20 Jun, 2008.)). Offsetting those findings, however, were data showing an increased risk of serious bleeding in patients receiving prasugrel. Out of every 1,000 patients treated, there were 23 fewer heart attacks in the prasugrel arm, but six more major bleeding events. FDA's decision in June to push back the action date for prasugrel spurred speculation that the NDA would be subject to an advisory committee review. Asked Aug. 21 for an update, Lilly only said it continues to await the Sept. 26 PDUFA date and has not been informed by FDA of any advisory committee hearing. Potential blockbuster or niche product? At least one industry analyst, Catherine Arnold of Credit Suisse, has predicted prasugrel will be a blockbuster - projecting peak sales of $1.5 billion by 2012. Bristol, however, asserts that prasugrel will be a "niche product" targeted to only 15 percent of ACS patients (3 (Also see "Bristol Readies For Prasugrel’s Impact On Plavix, Files DPP-4 Inhibitor" - Pink Sheet, 28 Jul, 2008.), p. 16). During Bristol's second-quarter earnings call July 24, Chief Operating Officer Lamberto Andreotti said his firm is ready to compete with prasugrel and will increase its hospital sales force for Plavix if prasugrel wins FDA approval. Plavix sales increased 19 percent year over year during the second quarter, to $1.2 billion, Bristol reported. Meanwhile, Lilly has made its own sales force preparations for a U.S. launch of Effient, by building a sales division that will target primary care physicians to complement its existing hospital sales force (4 (Also see "Prasugrel Sales Force Poised For FDA Decision In June, Lilly Says" - Pink Sheet, 21 Apr, 2008.)). Likewise, Daiichi Sankyo, which will market prasugrel in Europe, recently acquired 130 Germany-based sales representatives from Merck Serono to assist with sales of currently marketed products plus an anticipated launch of prasugrel (5 (Also see "Daiichi Sankyo Expands European Sales Presence By Hiring 130 Merck KGaA Reps" - Pink Sheet, 5 Aug, 2008.)). The drug was filed in the EU this past February. -Joseph Haas ([email protected]) |