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Arcoxia on track

This article was originally published in Pharmaceutical Approvals Monthly

Executive Summary

Merck is "on track" to re-submit Arcoxia in December, the firm tells analysts Dec. 9. Merck first submitted an NDA for the second-generation COX-2 inhibitor in 2001; the application was withdrawn due to concerns about cardiovascular safety and dosing for acute pain. The expanded NDA will cover osteoarthritis, rheumatoid arthritis, acute pain, dysmenorrhea, chronic lower back pain, acute gouty arthritis and ankylosing spondylitis. Merck noted no other coxib carries indications for the latter three indications. A late 2004 approval is predicted. While Arcoxia is three years behind Pfizer's follow-on COX-2 Bextra (valdecoxib), it could make it to market a year ahead of Novartis' Prexige, which was found "not approvable" Sept. 22 (1Pharmaceutical Approvals Monthly Oct. 1, 2003, In Brief)...
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