FDA to convene panel to consider Arcoxia.

FDA announced that it plans to convene a meeting of its Arthritis Advisory Committee Apr. 12 to discuss allowing Merck's arthritis drug Arcoxia on the U.S. market.

Arcoxia is sold in several countries outside the U.S. and belongs to the same class of drugs as Vioxx, which Merck pulled off the market in 2004 after it was linked to an increase in heart attack and strokes. Merck is seeking FDA permission to sell Arcoxia to treat osteoarthritis.

The drug is likely to face a tough review from FDA, which was criticized for its handling of safety problems involving COX-2 inhibitors. In 2005, FDA asked Pfizer to remove its COX-2 drug Bextra from the market. However, FDA did allow Pfizer to keep Celebrex on the market. Celebrex is now the only COX-2 drug approved for use in the U.S.

Merck first applied for FDA approval of Arcoxia of a range of uses

in 2001, submitting data from studies for uses such as relief of the signs and symptoms of osteoarthritis and rheumatoid arthritis, and management of acute and chronic pain. The company later withdrew its original application, because it wanted to resubmit the request for using Arcoxia in treating a spinal disorder known as ankylosing spondylitis, which it did in 2003. The meeting in April will consider whether to approve two dose levels of Arcoxia to treat symptoms of osteoarthritis.

Arcoxia, which is approved for sale in 62 other countries, is Merck's follow-up to Vioxx, the Cox-2 inhibitor it pulled from the market in 2004, after a study showed it elevated heart-attack risk.

Novartis has said it also plans to seek FDA approval this year for its COX-2 inhibitor Prexige.