Merck sends heart data on Vioxx successor to FDA

Last Updated: 2006-11-10 15:00:46 -0400 (Reuters Health)

NEW YORK (Reuters) - Merck & Co. Inc. on Friday said it sent data on heart risks to U.S. regulators in answer to concerns about its long-delayed arthritis drug Arcoxia, a potential successor to the withdrawn painkiller Vioxx.

Merck, which said the data would be made public on Monday, expects the U.S. Food and Drug Administration's latest review of Arcoxia to take about six months, until the end of April.

Arcoxia is in the same class as Vioxx, which Merck pulled off the market in September 2004 after a clinical trial found it increased the risk of heart attack and stroke.

Arcoxia is currently available in 62 countries but has been under review by the FDA since December 2003. Analysts are skeptical about its U.S. prospects in the wake of the withdrawal of Vioxx, which had annual sales of $2.5 billion.

The company said it is initially seeking approval of Arcoxia in 30-milligram and 60-milligram strengths for the symptomatic treatment of osteoarthritis.

The Whitehouse Station, New Jersey-based drug maker said it is continuing efforts with Arcoxia applications for other doses and conditions.

Merck said its response to approvable letters issued on Arcoxia by the FDA includes results of the "Medal" clinical trial. The trial, begun in 2002, was specifically designed to evaluate Arcoxia's cardiovascular risks.