Vioxx replacement Arcoxia shot down

Yesterday, an FDA panel voted 20 to 1 not to approve Arcoxia for osteoarthritis. Why such an overwhelming number?

Apparently, Arcoxia failed to prove that it served an unmet need. According to Merrill Goozner, Merck took some pretty poor evidence with them to the trial.

Merck stepped forward with an extremely weak set of data. They tested the drug in a staggering 34,000-plus patients, half of whom took diclofenac (sold as Voltaren or Cataflam), which has very low market penetration in the U.S. What it does have is a heart attack risk profile that is very similar to other Cox-2 inhibitors.

“What is the value of comparing it to diclofenac, which has an elevated cardiovascular risk?” asked [FDA safety officer David] Graham near the conclusion of his devastating critique. “It has no value.”

Ouch.

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