FDA Advisory Committee Recommends Against Approval for Merck's NDA for Arcoxia
WHITEHOUSE STATION, N.J. - Apr 12, 2007 - Merck & Co., Inc. announced today that the U.S. Food and Drug Administration's (FDA) Arthritis Advisory Committee voted against recommending approval at this time of ARCOXIA(R) (etoricoxib) for the symptomatic treatment of osteoarthritis in the United States. ARCOXIA has been under review by the FDA as an investigational selective COX-2 inhibitor since the New Drug Application (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.
"We are disappointed in today's outcome. We continue to believe that ARCOXIA has the potential to become a valuable treatment option for many Americans suffering from osteoarthritis, "said Peter Kim, Ph.D., president, Merck Research Laboratories. "We are committed to continuing to work with the FDA."
Merck presented data from a comprehensive and robust 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 7 additional studies in other patient populations; and robust data from the large 34,000-patient, long-term MEDAL (Multinational Etoricoxib and Diclofenac Arthritis Long-Term) Program. Merck continues to believe the overall benefit to risk profile is favorable to support approval of ARCOXIA for the proposed indication of treatment for the signs and symptoms of osteoarthritis.
The Committee's recommendation will be considered by the FDA as part of its review of the NDA that Merck filed in December 2003 (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. The FDA is not bound by the Committee's recommendation but takes its advice into consideration when reviewing the application for an investigational agent. The anticipated date for action by the FDA is April 27, 2007, the six-month timeframe under current FDA policy.
Merck will continue to market ARCOXIA outside the U.S., where it has been approved for a broad range of indications, including osteoarthritis.
About Merck
Merck & Co., Inc. is a global research-driven pharmaceutical company dedicated to putting patients first. Established in 1891, Merck currently discovers, develops, manufactures and markets vaccines and medicines to address unmet medical needs. The Company devotes extensive efforts to increase access to medicines through far-reaching programs that not only donate Merck medicines but help deliver them to the people who need them. Merck also publishes unbiased health information as a not-for-profit service. For more information, visit www.merck.com.
Forward-Looking Statement
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ARCOXIA(R) is a registered trademark of Merck & Co., Inc.