FDA Arthritis Advisory Panel Votes Against Approval of Etoricoxib for Osteoarthritis

Recently, the FDA Arthritis Advisory Committee reviewed the New Drug Application of the drug etoricoxib (Arcoxia), a COX-2 selective NSAID manufactured by Merck & Co., for use in the treatment of osteoarthritis pain.  After review of available clinical data and testimony by invited experts and the manufacturer, the Committee voted 20 to 1 not to recommend approval of the drug to the FDA based on concerns regarding the cardiovascular risk profile of the drug.  While not bound by the recommendations of the Committee, the FDA is expected to make further action recommendations in the next few weeks.  Etoricoxib is currently licensed for use outside the U.S., including in Europe.

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