Merck & Co, Inc. has received an "approvable" letter from the US FDA for the company's New Drug Application (NDA) for Arcoxia (etoricoxib). The FDA has informed Merck in the letter that before approval of the NDA can be issued, additional safety and efficacy data for Arcoxia are required.
"We continue to believe that Arcoxia has the potential to become a valuable treatment option for people with arthritis and pain," said Raymond V. Gilmartin, chairman, president and chief executive officer, Merck & Co., Inc. "We plan to work with the FDA to address what steps need to be taken before the application may be approved," he added.
The company submitted a revised NDA to the FDA on Dec. 30, 2003, to include efficacy data for ankylosing spondylitis and to provide additional cardiovascular safety data. In the NDA, Merck is seeking indications for Arcoxia for the treatment of osteoarthritis, rheumatoid arthritis, chronic low back pain, acute pain, dysmenorrhoea (menstrual pain), acute gouty arthritis and ankylosing spondylitis.
Arcoxia has been launched in 48 countries worldwide in Europe, Latin America and the Asia-Pacific region. Merck will continue to work with regulatory agencies in the countries where Arcoxia is approved, including the European Medicines Agency which recently announced plans for a safety review of the COX-2s, to assess whether changes to the prescribing information for this class of drugs, including Arcoxia, are warranted.