Ranexa Restricted Angina Indication Would Require New Study, Cmte. Says
Executive Summary
CV Therapeutics' Ranexa could receive a restricted indication for use in refractory angina patients with a new study in that population, FDA's Cardiovascular & Renal Drugs Advisory Committee said Dec. 9
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FDA requests additional Ranexa Phase III trial
Approval of CV Therapeutics' Ranexa (ranolazine) depends on outcome of additional Phase III angina trial comparing combination of Ranexa with Pfizer's Norvasc (amlodipine) versus Norvasc alone. Study designed under FDA's special protocol assessment program will involve 500 refractory chronic angina patients. Ranexa has been "approvable" at FDA since Oct. 30, 2003; the trial follows an FDA advisory committee recommendation from December (1"The Pink Sheet" Dec. 15, 2003, p. 42). Enrollment will start in the third quarter and be completed by the end of 2005, company says...