Merck Arcoxia Safety Board Allows Long-Term Trials To Continue
This article was originally published in The Pink Sheet Daily
The ongoing trials of etoricoxib are likely to continue through at least 2006. Merck is conducting the EDGE-2 and MEDAL studies to support resubmission of its NDA for the follow-on COX-2 inhibitor.
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The agency is seeking additional safety and efficacy data for the COX-2 inhibitor, the company says. Merck is working with international regulatory agencies on labeling changes for Arcoxia to address safety issues prompted by the Vioxx withdrawal.
Arcoxia's user fee date is Oct. 30, but FDA could decide to wait for 18-month cardiovascular safety data from a 20,000-patient trial comparing etoricoxib with diclofenac. Merck says it will work with regulatory authorities in 47 countries where Arcoxia is marketed to discuss potential labeling changes resulting from the Vioxx study data.