FDA Advisory Committee Votes Down Merck’s Arcoxia NDA

The FDA Arthritis Advisory Committee voted 20-to-1 against recommending approval of Merck’s Arcoxia for the symptomatic treatment of osteoarthritis. The drug has been under review by the FDA as an investigational selective COX-2 inhibitor since the NDA was submitted in December 2003 and is currently available in 63 countries in Europe, Latin America, the Asia-Pacific region and Middle East/Northern Africa.

Merck presented data from a comprehensive clinical program that included efficacy and safety findings for Arcoxia 30 mg and 60 mg once daily from 11 studies in patients with osteoarthritis; safety findings from seven additional studies in other patient populations; and data from a 34,000-patient, long-term MEDAL (Multinational Etoricoxib and Diclofenac Arthritis Long-Term) Program. Merck believes the overall benefit to risk profile is favorable to support approval of Arcoxia for treating the signs and symptoms of osteoarthritis.

The Committee’s recommendation will be considered by the FDA as part of its review of the NDA (for a 60 mg once daily dose) along with review of a separate related NDA for a 30 mg once daily dose of Arcoxia submitted in April 2004. Merck anticipates action by the FDA on April 27th.

The company will continue to market Arcoxia outside the U.S., where it has been approved for a broad range of indications, including osteoarthritis.