Novel blood clot drug Xarelto filed in U.S.
This article was originally published in Pharmaceutical Approvals Monthly
Executive Summary
Johnson & Johnson and Bayer file an NDA for Xarelto (rivaroxaban) July 29, following a positive recommendation July 25 by the EMEA's Committee for Medicinal Products for Human Use. The once-daily Factor Xa inhibitor is indicated for prevention of deep vein thrombosis and pulmonary embolism in patients undergoing hip or knee replacement surgery. If approved, the sponsors are hoping Xarelto's superior efficacy and safety profile from four Phase III studies in more than 12,500 patients would give it a leg up over warfarin and enoxaparin (Sanofi-Aventis' Lovenox) (1Pharmaceutical Approvals Monthly October 2007, p. 13). Xarelto's estimated user fee date is May 29, 2009
You may also be interested in...
Last Of The Primary Care Blockbusters? New Antithrombotics Line Up To Unseat Warfarin, Heparins, Plavix
Although the mainstays of antithrombotic therapy have remained the same for decades, a lengthy R&D assault by pharma – including some of the largest clinical trials ever conducted – has produced potential game-changers that have made it to FDA review for both major blood clot approaches: anticoagulation and platelet inhibition.
Sanofi Will Establish Lovenox Follow-On In Series Of Head-To-Head Trials
Sanofi-Aventis is looking to establish its ultra low molecular weight heparin product AVE5026 - a follow-on to the firm's Lovenox - as more efficacious than enoxaparin in preventing venous thromboembolic events through a series of head-to-head trials against Lovenox
Pink Sheet Podcast: Leqembi Spending, Woodcock’s Next Act, Pneumococcal Vaccine Development
Pink Sheet editors discuss Medicare spending projections for the Alzheimer’s treatment Leqembi, Janet Woodcock’s new post-FDA role, and ongoing preparations for new pneumococcal vaccines that will reach the market soon.