Merck Receives Non Approvable Letter from FDA for ARCOXIA(R) (etoricoxib).WHITEHOUSE STATION, N.J. -- Merck & Co., Inc., announced today that the U.S. Food and Drug Administration (FDA FDA abbr. Food and Drug Administration FDA, n.pr See Food and Drug Administration. FDA, n.pr the abbreviation for the Food and Drug Administration. ) issued a non-approvable letter in response to the Company's New Drug Application (NDA (Non Disclosure Agreement) An agreement signed between two parties that have to disclose confidential information to each other in order to do business. In general, the NDA states why the information is being divulged and stipulates that it cannot be used for any ) for ARCOXIA([R]) (etoricoxib) for the symptomatic treatment of osteoarthritis osteoarthritis or osteoarthrosis or degenerative joint disease Most common joint disorder, afflicting over 80% of those who reach age 70. It does not involve excessive inflammation and may have no symptoms, especially at first. (OA). ARCOXIA has been under review by the FDA as an investigational selective COX-2 inhibitor cox-2 inhibitor: see nonsteroidal anti-inflammatory drug. 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 NSAID: see nonsteroidal anti-inflammatory drug. , 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. 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 forward-looking statement A projected financial statement based on management expectations. A forward-looking statement involves risks with regard to the accuracy of assumptions underlying the projections. This press release contains "forward-looking statements" as that term is defined in the Private Securities Litigation Reform Act The Private Securities Litigation Reform Act of 1995 (PSLRA) implemented several significant substantive changes affecting certain cases brought under the federal securities laws, including changes related to pleading, discovery, liability, class representation and awards fees and 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 Form 10-K A report required by the SEC from exchange-listed companies that provides for annual disclosure of certain financial information. Form 10-K See 10-K. for the year ended Dec. 31, 2006, and in its periodic reports on Form 10-Q Form 10-Q See 10-Q. and Form 8-K, which the Company incorporates by reference. ARCOXIA(R) is a registered trademark of Merck & Co., Inc. |
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