FDA: Merck’s Arcoxia is Non-Approvable

Confirming a virtually certain outcome, U.S. drug maker Merck said Friday it received a non-approvable letter for its new Cox-2 inhibitor Arcoxia.

In the non-approvable letter, the U.S. Food and Drug Administration told Merck it would need more data on the benefit-to-risk profile for the 60-mg and 30-mg daily doses proposed for Arcoxia to get approval.

The company was hoping to win FDA clearance for the drug as a pain treatment for osteroarthritis, to replace its earlier generation Cox-2 Vioxx, which was withdrawn from the market in September 2004.

However, earlier this month, an FDA advisory panel voted to reject Arcoxia for market approval and, amid heightened scrutiny of the safety of the drugs the FDA releases to the marketplace, the agency was virtually certain to go along.

We are disappointed with today’s decision, said Peter Kim, president of Merck Research Laboratories, in a statement issued Friday. We pursued FDA approval of Arcoxia because we believe strongly that new medicines are needed for patients whose osteoarthritis pain is inadequately managed with currently available therapies.

He added, In addition, there is more long-term safety data from controlled clinical trials, in terms of patient-years on treatment, for Arcoxia than for any other (non-steroidal anti-inflammatory drugs), including traditional NSAIDs and Cox-2 selective inhibitors.

Arcoxia is approved in 63 countries in Europe, Latin America, the Asia-Pacific region and Middle East/Northern Africa, Merck said.

The COX-2 inhibitor class of painkillers — of which Celebrex is the only such drug still on the U.S. market — has a lower risk of gastrointestinal bleeding events like stomach ulcers, compared to NSAIDs. However, COX-2s have been linked to a greater risk of heart attack and stroke when used long-term.