CVT Ranexa complete response
This article was originally published in Pharmaceutical Approvals Monthly
Executive Summary
CV Therapeutics submits its "complete response" to an October 2003 "approvable" letter for its angina treatment Ranexa (ranolazine) July 27. The amendment seeks a narrowed indication based on the FDA-requested ERICA (Evaluation of Ranolazine in Chronic Angina) study of patients refractory to Pfizer's Norvasc (amlodipine), which compared the partial fatty acid oxidation inhibitor plus the maximum labeled dose (10 mg) of Norvasc to Norvasc alone. CVT has said that the 0.4 attack/week reduction seen in ERICA was sufficient for an indication for a restricted population, despite being less than half the projected 1.0-1.2 reduction (1Pharmaceutical Approvals Monthly May 2005, p. 10). Assuming a six-month review of the amendment, Ranexa could launch in the first half of 2006...
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CV Therapeutics submits its "complete response" to an October 2003 "approvable" letter for its angina treatment Ranexa (ranolazine) July 27. The amendment seeks a narrowed indication based on the FDA-requested ERICA (Evaluation of Ranolazine in Chronic Angina) study of patients refractory to Pfizer's Norvasc (amlodipine), which compared the partial fatty acid oxidation inhibitor plus the maximum labeled dose (10 mg) of Norvasc to Norvasc alone. CVT has said that the 0.4 attack/week reduction seen in ERICA was sufficient for an indication for a restricted population, despite being less than half the projected 1.0-1.2 reduction (1 Pharmaceutical Approvals Monthly May 2005, p. 10). Assuming a six-month review of the amendment, Ranexa could launch in the first half of 2006.... |