Ranexa ahead of schedule
This article was originally published in Pharmaceutical Approvals Monthly
Executive Summary
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)...
You may also be interested in...
Ranexa Could Be First Approval For First-Line Angina With MERLIN Trial
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.
Japan Grants Global-First Approval To Zolbetuximab, 15 Other New Drugs
Astellas's first-in class CLDN18.2-targeting antibody receives its first approval worldwide, while crovalimab and a number of drugs for rare diseases also receive nods from regulators and are now awaiting reimbursement price-listing.
Hanmi-OCI Merger Hits Wall As Brothers Win Shareholder Vote, Board Seats
The planned merger of Korea's Hanmi Pharm Group with OCI Group hits a major speed bump as the two sons of Hanmi's founder and other candidates recommended by them secture board seats. But it remains to be seen how the Lim brothers will fulfil their ambitious promises.