Merck has received an 'approvable' letter from the FDA for Arcoxia but will need to provide further information before its arthritis treatment is approved.

A recent 7,111 patient study of osteoarthritis patients showed they had no greater incidence of heart attacks than patients taking diclofenac sodium, a commonly prescribed non-steroidal anti-inflammatory drug (NSAID), but the FDA told Merck it requires additional safety and efficacy data before approving the Cox-II inhibitor.

The EDGE (Etoricoxib Diclofenac Gastrointestinal Evaluation) study also found that fewer patients stopped taking Arcoxia due to gastrointestinal side-effects, compared to those on the NSAID.

Merck had hoped that Arcoxia would fill the gap left by the recent withdrawal of its blockbuster Vioxx, which made £2.5 billion in annual sales, accounting for 10% of the company's 2003 revenues.

Already launched in 48 countries, Arcoxia was predicted to reach blockbuster status, with sales of $1 billion by 2008.

Vioxx was withdrawn at the end of September after it was found to double the risk of heart attack and stroke in patients who had been taking it for at least 18 months.

Merck's chairman, president and chief executive officer Raymond Gilmartin, said: "We continue to believe that Arcoxia has the potential to become a valuable treatment option for many Americans with arthritis and pain. We plan to work with the FDA to address what steps need to be taken before the application may be approved."

Arcoxia had been submitted to the FDA as a treatment for a number of different indications including osteoarthritis and rheumatoid arthritis, acute pain and ankylosing spondylitis.

The FDA's decision will increase speculation that the regulators may not make a final decision on Arcoxia until 2006, because of its links to Vioxx and the need for longer clinical trials.

The approval may present an opportunity to Pfizer's Celebrex ­ which earned $2.7 billion in 2003 - the only remaining drug in the class with several years' post-marketing safety and efficacy data.

Merck will continue to work with regulatory agencies in the countries where Arcoxia is approved, including the EMEA, which recently announced plans for a safety review of all Cox-IIs, including Arcoxia, to assess whether changes to prescribing information was warranted.

Related articles:

Pfizer distances Celebrex from COX-II safety concerns

Thursday , October 07, 2004

pharmafocus@wiley.co.uk