Merck to re-file New Drug Application for Arcoxia next year
WHITEHOUSE STATION, N.J. -- Merck & Co announced plans to re-file an expanded New Drug Application (NDA) for Arcoxia (etoricoxib) with the U.S. Food and Drug Administration (FDA) in the second half of 2003.
Merck has been in ongoing discussions with the FDA since the withdrawal of the original U.S. NDA for Arcoxia on March 15, this year. In a meeting last week, the FDA requested additional data on the acute pain indications for Arcoxia, and additional cardiovascular safety data for Arvoxia versus comparators other then naproxen.
In order to enhance its filing for a broad range of acute pain indications, including gout, Merck will provide data from several ongoing studies on Arcoxia in acute pain. In response to the FDA's request for additional data on the cardiovascular safety of Arcoxia, Merck soon will be enrolling patients in a large clinical trial comparing Arcoxia to a non-naproxen, non-steroidal anti-inflammatory drug. Both gastrointestinal and cardiovascular safety data will be collected in this study. As previously announced, Merck will be submitting additional efficacy data to support a new indication for ankylosing spondylitis, which is a chronic, inflammatory disorder primarily involving the spine. Merck also will seek indications for osteoarthritis, rheumatoid arthritis, chronic pain, acute pain, dysmenorrhea (menstrual pain) and acute gouty arthritis.
Arcoxia has been approved for use in Mexico, Brazil, Peru and the United Kingdom. Merck expects to receive regulatory approval of the drug in other European countries over the next few months.
Merck's other coxib product, Vioxx (rofecoxib) is the only coxib with proven risk reductions in gastrointestinal events versus naproxen.
Posted: June 2002