Quality By Design Pilot Found Unprecedented Manufacturing Quirk For Effient
This article was originally published in Pharmaceutical Approvals Monthly
Lilly's participation in an FDA manufacturing pilot program designed to maximize efficiency and agility appears to have uncovered an unusual issue that further complicated the lengthy and overdue review of the Effient (prasugrel) NDA - but, serendipitously, may have laid the groundwork for another fortuitous comparison for Effient in its commercial battle with Plavix
You may also be interested in...
FDA Updates Plavix Label, Leaves Effient With Clear Advantage
FDA expands upon the warning that it discreetly slipped into the anti-clotting drug's labeling in May, with new data that clopidogrel is 50% less effective when given with Prilosec.
"Silent" MIs Outweigh "Scary" Bleeds, FDA Concludes In Effient Review
FDA's approval of Lilly/Daiichi Sankyo's antiplatelet agent Effient (prasugrel) reflects the review team’s willingness to look past the increased risk of bleeding – a dramatic and viscerally alarming adverse event, though understandable due to the medical setting – to see the less immediately apparent benefit of a reduction in a type of cardiac event that includes so-called "silent MIs" that have no visible clinical presentation.
FDA Priority Review Voucher Redemption Fee Set At $4.6 Million In FY 2011
Redeeming a priority review voucher obtained by developing a drug for a tropical disease will cost companies $6.1 million in fiscal 2011