Company expects final decision on Arcoxia, allowed outside the U.S., in April.
Merck & Co. reported that the FDA’s Arthritis Advisory Committee voted against the approval of Arcoxia for the symptomatic treatment of osteoarthritis.
“We are committed to continuing to work with the FDA to discuss the application in an effort to gain U.S. regulatory approval for Arcoxia,” states Peter Kim, Ph.D., president, Merck Research Laboratories. The company believes that the overall benefit-to-risk profile is favorable to support approval of the drug to treat signs and symptoms of osteoarthritis.
Arcoxia is a selective COX-2 inhibitor. It is currently available in 63 countries in Europe, Latin America, the Asia-Pacific region, and Middle East/Northern Africa, according to Merck, for a broad range of indications, including osteoarthritis.
The company presented data which showed efficacy and safety of Arcoxia 30 mg and 60 mg once-daily. The results were taken from 11 studies in patients with osteoarthritis, safety findings from seven additional trials in other patient populations, and a 34,000-patient, long-term MEDAL (Multinational Etoricoxib and Diclofenac Arthritis Long-Term) Program.
The FDA will consider the Committee’s recommendation in review of the NDA Merck filed in December 2003 for a 60-mg, once-daily dose along with a separate NDA for a 30-mg, once-daily dose, submitted in April 2004. Merck anticipates the FDA to reach its decision by April 27.
