European Commission Adopts European Medicines Agency (EMEA) Recommendations on ARCOXIA™ (etoricoxib) 90 mg |
WHITEHOUSE STATION, N.J., Sept. 29, 2008 - Merck & Co., Inc. today confirmed that the European Commission (EC) adopted the recommendation of the European Medicines Agency (EMEA) to approve ARCOXIA™ (etoricoxib) 90 mg once daily as a new treatment for ankylosing spondylitis, maintain the 90 mg dose for rheumatoid arthritis, and modify the contraindications and warnings sections of the label for treating and monitoring patients with hypertension. The Commission's action affirms the value of ARCOXIA as a therapeutic option for the treatment of a broad range of conditions. In Europe, ARCOXIA is indicated for the treatment of osteoarthritis (30 mg or 60 mg), rheumatoid arthritis (90 mg) and acute gouty arthritis (120 mg). National approval procedures to implement the new indication and prescribing information are expected to begin soon in the 27 member states of the European Union. ARCOXIA is approved and launched in 69 countries in Europe, Latin America and the Asia-Pacific region. About ARCOXIA ARCOXIA may be associated with more frequent and severe hypertension than some other NSAIDS and selective COX-2 inhibitors, particularly at high doses. As part of the EMEA's recommendations the product label was modified to state that patients with uncontrolled hypertension (blood pressure persistently above 140/90 mm Hg) not take ARCOXIA. Additionally, label warning language has been modified to state that high blood pressure needs to be controlled prior to treatment with etoricoxib and that blood pressure should be monitored within two weeks of starting etoricoxib and periodically thereafter. Upper GI ulcers/ulcer complications have occurred in patients treated with ARCOXIA. ARCOXIA has been studied and approved in a broad range of chronic and acute conditions, including osteoarthritis, adult rheumatoid arthritis and acute gouty arthritis. ARCOXIA is indicated for the symptomatic relief of: rheumatoid arthritis (90mg) acute gouty arthritis (120 mg) ankylosing spondylitis (90mg) and osteoarthritis (30mg or 60mg). The dose for each indication is the maximum recommended daily dose, except for osteoarthritis, which has a maximum recommended daily dose of 60 mg. ARCOXIA 120 mg should be used only for the acute symptomatic period (maximum use 8 days). Forward-Looking Statement |
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