Merck, Schering-Plough resolve Vytorin investigation
This article was originally published in The Tan Sheet
Executive Summary
Merck and Schering-Plough will pay $5.4 million to 35 states and the District of Columbia to resolve an investigation into the firms' delayed release of negative study results for the cholesterol-lowering drug Vytorin. The agreement, which is not an admission of liability, covers the states' and D.C.'s investigative costs. The ENHANCE trial found Vytorin was no more effective in reducing plaque in carotid arteries than simvastin (1"The Tan Sheet" Feb. 4, 2008)
You may also be interested in...
FDA on ENHANCE
The agency will review the recently completed study of the Merck/Schering-Plough combination cholesterol therapy Vytorin after it receives the final results, according to a Jan. 25 announcement. The study found "no statistically significant differences" between a group receiving the highest dose of Vytorin (10 mg ezetimibe plus 80 mg simvastatin) and a group receiving 80 mg simvastatin in either the primary endpoint or in key secondary imaging endpoints (1"The Tan Sheet" Jan. 21, 2008, p. 12). Investigators in the firms' ENHANCE trial determined the primary endpoint - mean change in the intima-media thickness - through ultrasound measurements of the carotid arteries. FDA said it is not clear why the lower levels of LDL cholesterol in patients who took Vytorin did not lead to lesser amounts of plaque, compared to patients treated with simvastatin alone...
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.