Ranexa Could Be First Approval For First-Line Angina With MERLIN Trial
This article was originally published in Pharmaceutical Approvals Monthly
CV Therapeutics’ Ranexa could receive the first approval for first-line treatment of chronic angina if a new outcomes trial does not detect a trend towards death or arrhythmia, the company said.
You may also be interested in...
A mean weekly reduction of 0.4 angina attacks seen in the ERICA study with CV Therapeutics' Ranexa (ranolazine) is adequate for approval, the company said, despite being less than half the expected decrease
CV 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)...
An "approvable" action was three times more likely than approval for the new molecular entities with user fee goals in October, according to an analysis by Pharmaceutical Approvals Monthly.