Ranexa ahead of schedule
This article was originally published in Pharmaceutical Approvals Monthly
Executive SummaryCV Therapeutics expects to complete enrollment of its "approval-enabling study" of Ranexa by the end of the first quarter of 2005, the firm says Oct. 26. Prior to initiation in August 2004, the firm expected to complete enrollment of the Evaluation of Ranolazine In Chronic Angina study by the end of 2005. ERICA is being conducted under a special protocol assessment with FDA and is comparing ranolazine to the calcium channel blocker amlodipine (Pfizer's Norvasc) in 500 refractory chronic angina patients. Ranexa has been "approvable" at FDA since Oct. 30, 2003. Another study, MERLIN, is ongoing in support of a first-line indication (1Pharmaceutical Approvals Monthly Aug. 1, 2004, p. 10)...
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