FDA Rejects Merck Drug

The decision on Arcoxia had been expected.
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Merck

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said Friday that the Food and Drug Administration rejected its bid to market Arcoxia, a pain reliever in the same drug class as Vioxx.

The decision had been expected. On April 13, an FDA advisory panel of outside medical experts voted 20-1 against recommending the drug as a treatment for osteoarthritis. The advisors said the potential cardiovascular risks outweighed the benefits.

Shares of Merck were down 48 cents, or 1%, to $51.95.

The FDA said the company would need "additional data to support the benefit-to-risk profile" to gain approval, Merck said.

"We are disappointed with today's decision," said Peter Kim, president of Merck Research Laboratories. "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."

Merck said it will continue to market Arcoxia in the 63 countries where it is currently available. Merck didn't offer any immediate comment on whether it would halt its effort to seek FDA approval. Arcoxia had sales of $265 million last year.

Like Vioxx, which Merck withdrew in September 2004 due to safety concerns, Arcoxia is a COX-2 inhibitor. The only COX-2 drug available in the U.S. is

Pfizer's

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Celebrex.

Pfizer removed another COX-2 drug, Bextra, from the market in early 2005 when the FDA said tests showed its risks outweighed its benefits.

Merck was facing an uphill climb on Arcoxia not only from the advisory panel's comments, but also from the FDA's recent remarks that any experimental pain reliever would face a tougher review than had previous compounds. The key issues include cardiovascular side effects and a "reasonable risk-to-benefit balance," the agency says.

Ironically, Arcoxia fared worse with its FDA advisory panel vote than Vioxx did. Five months after Vioxx was pulled, a pair of FDA advisory panels met in February 2005 to review several COX-2 drugs. Vioxx got a favorable vote of 17-15 as panel members said it could return to the market, with restrictions, for certain patients. Merck hasn't talked about reviving Vioxx.

The advisers also endorsed Celebrex by a 31-1 vote, and they backed Bextra by 17-13 with two abstentions. Two months later, however, the FDA overruled the panel on Bextra, telling Pfizer to stop selling it.

The vote on Arcoxia and the FDA's vow of tougher pain-reliever standards will undoubtedly cause concern for investors in

Novartis

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. The Swiss drugmaker submitted an application to the FDA in March for Prexige as a treatment for osteoarthritis of the knee and hip.

The European Union gave the go-ahead for Prexige in November. The drug is sold in eight countries.