ArcoxiaTreatment for Osteoarthritis
Merck Responds to FDA-Issued Approvable Letters for Arcoxia (etoricoxib)
WHITEHOUSE STATION, N.J., November 10, 2006 -- Merck & Co., Inc. today announced that it has submitted a response to the "approvable" letters on the New Drug Applications (NDAs) for Arcoxia (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.
Source: Merck & Co., Inc.
Posted: November 2006
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