Healthcare Industry News: COX-2 inhibitor
News Release - November 10, 2006
Merck Responds to FDA-Issued Approvable Letters for Arcoxia(R) (etoricoxib)WHITEHOUSE STATION, N.J.--(HSMN NewsFeed)--Merck & Co., Inc. today announced that it has submitted a response to the "approvable" letters on the New Drug Applications (NDAs) for ArcoxiaŽ (etoricoxib) issued by the U.S. Food and Drug Administration (FDA). According to current FDA policy for this type of submission, the review is targeted to be approximately six months (end of April 2007). The original NDA was submitted in December 2003 and a separate related NDA to add a 30 mg dose of ARCOXIA was submitted in April 2004. ARCOXIA has been under review by the FDA as an investigational selective COX-2 inhibitor since the original NDA was submitted in December 2003 and is currently available in 62 countries in Europe, Latin America, the Asia-Pacific region and Middle East/Northern Africa.
As noted in its response to the FDA, the Company is initially seeking approval of ARCOXIA only for the symptomatic treatment of osteoarthritis for both ARCOXIA 30 mg once daily and ARCOXIA 60 mg once daily. The Company is continuing its efforts with respect to other doses and indications to support subsequent U.S. supplemental NDAs.
The response to the approvable letters includes the results of the MEDAL (Multinational Etoricoxib and Diclofenac Arthritis Long-Term) Program, the first arthritis study program to have cardiovascular events as a primary endpoint. These results of the MEDAL Program, which began in 2002, will be made publicly available on Monday, Nov. 13 in a scientific peer-reviewed publication and in presentations at scientific meetings of the American Heart Association and American College of Rheumatology. These results from the MEDAL Program are also being submitted to regulatory authorities in all countries where ARCOXIA is approved or currently under review.
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 cautionary statements in Item 1 of Merck's Form 10-K for the year ended Dec. 31, 2005, and in its periodic reports on Form 10-Q and Form 8-K, which the Company incorporates by reference.
ArcoxiaŽ is a registered trademark of Merck & Co., Inc.
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