Merck, Sharp & Dohme (MSD) today announced that the European Medicines Agency Committee for Medicinal Products for Human Use (CHMP) has completed the review of ARCOXIA (TM) (etoricoxib) for the treatment of rheumatoid arthritis (RA) and ankylosing spondylitis (AS) and concluded that the benefits outweigh the risks for the treatment of these conditions. The CHMP recommended extension of the indications for ARCOXIA (TM) (etoricoxib) to include ankylosing spondylitis (AS) at 90 mg once daily and maintaining the indication for rheumatoid arthritis (RA) at 90 mg once daily. In addition, the CHMP recommended strengthening the existing contraindication for patients with uncontrolled hypertension and the warnings regarding treatment and monitoring of patients with high blood pressure. MSD considers that this comprehensive review of the use of ARCOXIA (TM) (etoricoxib) in RA and AS affirms the value of this therapeutic option for patients with these debilitating diseases, in addition to osteoarthritis and acute gouty arthritis, when used according to the approved label information.
The review by the CHMP concludes two separate referrals that were initiated to assess the benefits and risks for the treatment of RA and AS at a dose of 90mg. MSD will continue to collaborate with CHMP to provide additional information and data on ARCOXIA(TM) (etoricoxib).
The CHMP recommended that the existing contraindication in patients with uncontrolled hypertension be strengthened to indicate that patients whose blood pressure is persistently above 140/90 mm Hg and not adequately controlled not take ARCOXIA(TM) (etoricoxib). In addition, the label warnings were recommended to be updated to indicate that high blood pressure should be controlled prior to treatment, monitored within 2 weeks of treatment and periodically thereafter.
Pending the adoption of the CHMP opinion by the European Commission, the outcome of these referrals will apply to the 27 countries that are members of the EU, plus Norway and Iceland.
About rheumatoid arthritis and ankylosing spondylitis
Rheumatoid Arthritis is a chronic disease mainly characterized by inflammation of the lining of the joints. It can lead to long term joint damage, resulting in chronic pain, loss of function and disability. It affects mostly women and onset usually occurs between 30 and 50 years of age.
Ankylosing spondylitis is a chronic, autoimmune disease that primarily affects the spine, usually leading to pain, stiffness and immobility of the lower back. Men are more commonly affected than women, and the age of onset is usually between ages 16 and 35. Although the cause of the disease is unknown, genetics appears to play a role.
About ARCOXIA
ARCOXIA is an NSAID which works by inhibiting cyclooxygenase–2 (COX–2), the enzyme responsible for pain and inflammation. Clinical trials suggest that COX–II inhibitors may be associated with an increased risk of thrombotic events (especially MI and stroke), relative to placebo and some NSAIDS. ARCOXIA is not a substitute for aspirin for cardiovascular prophylaxis because of its lack of effect on platelets. ARCOXIA may be associated with more frequent and severe hypertension than some other NSAIDS and selective COX–2 inhibitors, particularly at high doses. 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 has been approved and launched in 68 countries in Europe, Latin America and the Asia–Pacific region.
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).
About Merck Sharp & Dohme
Merck & Co., Inc. (Whitehouse Station, N.J., U.S.A.), which operates in many countries as Merck Sharp & Dohme or MSD, is a global research–driven pharmaceutical company dedicated to putting patients first. Established in 1891, the Company 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 its medicines but help deliver them to the people who need them. Merck (Whitehouse Station, N.J., U.S.A.) also publishes unbiased health information as a not–for–profit service. For more information, visit www.merck.com.
Forward–Looking Statement
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 the Company´s business, particularly those mentioned in the risk factors and cautionary statements in Item 1A of The Company´s Form 10–K for the year ended Dec. 31, 2007, and in any risk factors or cautionary statements contained in the Company´s periodic reports on Form 10–Q or current reports on Form 8–K, which the Company incorporates by reference.