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COX-2 class reunion? Prexige, Arcoxia inch forward

This article was originally published in Pharmaceutical Approvals Monthly

Executive Summary

Merck's resubmitted NDA for Arcoxia (etoricoxib) seeks a narrowed indication for treatment of osteoarthritis only; the original NDA for the follow-on to Merck's now-withdrawn Vioxx, submitted in 2003, sought uses in OA, RA, chronic low-back pain, acute pain, dysmenorrhea, gouty arthritis and ankylosing spondylitis. Merck anticipates a six-month review, with a user fee goal at the end of April 2007. Novartis plans to resubmit its COX-2 inhibitor Prexige (lumiracoxib) in the first half of 2007; the NDA has been "not approvable" since 2003. On Nov. 7, Novartis announced approval of Prexige for osteoarthritis in the European Union and Canada...

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