WHITEHOUSE STATION, N.J.--(BUSINESS WIRE)--Merck & Co., Inc., announced today that the U.S. Food and Drug Administration (FDA) issued a non-approvable letter in response to the Company's New Drug Application (NDA) for ARCOXIA® (etoricoxib) for the symptomatic treatment of osteoarthritis (OA). ARCOXIA has been under review by the FDA as an investigational selective COX-2 inhibitor since the NDA was submitted 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 submitted in April 2004.
In the non-approvable letter, the FDA indicated that Merck would need to provide additional data in support of the benefit-to-risk profile for the proposed doses of ARCOXIA in order to gain approval.
"We are disappointed with today's decision,” said Peter S. Kim, Ph.D., president, Merck Research Laboratories. “We pursued FDA approval of ARCOXIA because we believe strongly that new medicines are needed for patients whose osteoarthritis pain is inadequately managed with currently available therapies. In addition, there is more long-term safety data from controlled clinical trials, in terms of patient-years on treatment, for ARCOXIA than for any other NSAID, including traditional NSAIDs and Cox-2 selective inhibitors.”
ARCOXIA is available in 63 countries in Europe, Latin America, the Asia-Pacific region and Middle East/Northern Africa. Merck will continue to market ARCOXIA outside the United States, where it has been approved for a broad range of indications, including OA.
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.
This press release contains "forward-looking statements" as that term is defined in the Private Securities Litigation Reform Act of 1995. These statements are based on management's current expectations and involve risks and uncertainties, which may cause results to differ materially from those set forth in the statements. The forward-looking statements may include statements regarding product development, product potential or financial performance. No forward-looking statement can be guaranteed and actual results may differ materially from those projected. Merck undertakes no obligation to publicly update any forward-looking statement, whether as a result of new information, future events, or otherwise. Forward-looking statements in this press release should be evaluated together with the many uncertainties that affect Merck's business, particularly those mentioned in the risk factors and cautionary statements in Item 1A of Merck's Form 10-K for the year ended Dec. 31, 2006, and in its periodic reports on Form 10-Q and Form 8-K, which the Company incorporates by reference.
ARCOXIA(R) is a registered trademark of Merck & Co., Inc.