Processing Magazine

FDA rejects Merck''s Vioxx successor

April 30, 2007

Merck & Co. said that U.S. regulators have rejected its arthritis drug Arcoxia, the drugmaker''s follow-up to Vioxx, informing the company it cannot be approved without new supportive data, according to Reuters. The rejection by the U.S. Food and Drug Administration came after an advisory panel to the agency earlier this month recommended against Arcoxia''s approval. Members of the U.S. advisory panel, by a lopsided vote, had spurned 30-milligram and 60-milligram doses of the drug, saying the medicine could damage the heart and had not shown any benefits over the approximately 20 pain relievers already on the market. The FDA said it could not be approved for osteoarthritis without "additional data in support of the benefit-to-risk profile for the proposed doses of Arcoxia," Merck said on Friday. Osteoarthritis is the most common form of arthritis, caused by wear and tear of the joints.