Complete MEDAL Data May Forge Arcoxia Approval
This article was originally published in The Pink Sheet Daily
Executive Summary
Clinical data presented by Merck is not qualitatively different from preliminary release of trial results for the COX-2 inhibitor.
You may also be interested in...
Use Of Highly Selective NSAID Comparator In Arcoxia Trials Remains Controversial
Merck’s Arcoxia should not be approved based on a comparison to diclofenac in the MEDAL studies, Cleveland Clinic’s Nissen says.
Use Of Highly Selective NSAID Comparator In Arcoxia Trials Remains Controversial
Merck’s Arcoxia should not be approved based on a comparison to diclofenac in the MEDAL studies, Cleveland Clinic’s Nissen says.
Merck Seeks Narrowed Arcoxia Indication In Response To “Approvable” Letter
Company expects to hear from FDA in April on 30 mg and 60 mg once-daily doses of the Vioxx follow-on drug.