Where is arcoxia approved

Arcoxia etoricoxib is a therapy marketed by Merck to manage the symptoms of joint pain and swelling that accompany osteoarthritis OA , rheumatoid arthritis RA , gouty arthritis, and ankylosing spondylitis AS. It is approved in many countries around the globe but it is not approved by the U. Food and Drug Administration.

COX enzymes promote reactions that increase the production of prostaglandins , chemicals that cause pain and inflammation at sites of injury. Blocking COX enzymes means fewer prostaglandins will be made, therefore reducing joint pain and swelling. COX-1 contributes to inflammation but it also helps protect the lining of the stomach, so blocking COX-1 makes the stomach vulnerable to injury.

One of the first studies to document the effectiveness of Arcoxia in individuals with AS was published in The randomized, double-blind trial found that 90 mg and mg doses of Arcoxia relieved pain and improved function more effectively than placebo, with about the same safety profile as naproxen. A more recent Phase 3 randomized, multicenter clinical trial NCT also compared the efficacy and safety of different doses of Arcoxia in patients with AS.

The results, published in the scientific journal BMC Musculoskeletal Disorders in , showed that both 60 mg and 90 mg doses of the drug controlled pain in patients with AS, establishing 60 mg as the lowest effective dose for most patients.

Arcoxia is not approved in the U. COX-2 inhibitors can increase blood pressure and may damage the lining of blood vessels , increasing the risk of strokes and heart attacks.

The FDA said they needed more evidence to show that the benefits of Arcoxia outweigh its risks. The risk is greatest when high doses are used over a long period of time.

Drug utilisation data showed that some patients with high blood pressure are being initiated on etoricoxib. The CHMP therefore recommended the strengthening of the contraindication in hypertensive patients and alerts prescribers that blood pressure needs to be monitored, especially within 2 weeks of treatment initiation. Healthcare professionals were to be reminded of these measures through a communication letter Dear Healthcare Professional Letter.

Data from clinical studies showed clinically meaningful treatment effect for the 90mg etoricoxib once daily dose for AS indication; however, some data are available to indicate that lower doses might also show effect. The CHMP therefore recommended that dose finding studies should be explored to conclude if treatment with 60mg once daily would also be adequate for some patients.

Based on the review of the available data, the CHMP considered that the benefits of etoricoxib outweigh the risks in the treatment of ankylosing spondylitis. The list of product names concerned is given in Annex I.

This type of referral was triggered for a medicine that had been authorised by mutual recognition or via the decentralised procedure when there was disagreement between Member States on a variation type II. This referral has been replaced by Article 13 referrals.

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Table of contents Overview Key facts All documents. Current status. Etoricoxib is a selective inhibitor of COX-2 cyclooxygenase 2 indicated in the symptomatic relief of osteoarthritis OA, mg once daily od , rheumatoid arthritis RA, 90mg od and the pain and signs of inflammation associated with acute gouty arthritis mg od This referral procedure relates to a request for arbitration concerning a type II variation for a new indication to include treatment of ankylosing spondylitis AS , at a recommended daily dose of 90mg.

The final opinion was converted into a decision by the European Commission on 9 September Key facts. Article 6 12 referrals prior to January All documents. List item. Description of documents published Please note that some of the listed documents apply only to certain procedures. How useful was this page?