FDAnews
www.fdanews.com/articles/90322-fda-advisory-committee-to-consider-merck-s-arcoxia

FDA ADVISORY COMMITTEE TO CONSIDER MERCK'S ARCOXIA

March 5, 2007

Merck has been told by the FDA that its new drug application (NDA) for Arcoxia (etoricoxib) will be reviewed by the agency's Arthritis Advisory Committee April 12.

Merck is seeking approval of Arcoxia for the symptomatic treatment of osteoarthritis. The company said it looks forward to presenting data from its Arcoxia clinical program in April.

The company originally submitted a new drug application for the drug in 2003 and received an FDA approvable letter, which it responded to in November 2006 by submitting data from its MEDAL study showing that Arcoxia has similar rates of adverse cardiovascular events as diclofenac. At the time Merck said it expected an FDA decision on the drug in April.

Data from the same study showing that overall upper gastrointestinal events were significantly less common with Arcoxia than with diclofenac were recently published in The Lancet. Arcoxia is currently available in 62 countries in Europe, Latin America, Asia and the Middle East.