On April 12th, a Food and Drug Administration, FDA, advisory panel of experts rejected Merck’s drug, Arcoxia, in a 20-1 vote. It is a non-binding recommendation that the FDA should not approve the drug for the U.S. market. The FDA will be taken as advice and one factor to consider when the FDA is makes its decision whether or not to approve the drug. Merck is seeking approval of the drug for the treatment of osteoarthritis.
According to news reports, the Arcoxia is already available in more than 60 countries and it made over $250 million for the drug manufacturer in 2006, although that is a relatively small number. It is reported that Merck’s sales were more than $22 billion dollars last year.
News reports quote an FDA scientist, Dr. David Graham, as calling the drug “a potential public health disaster.” He also said that the U.S. “could have a replay of what we had with refecoxib.” Refecoxib was manufactured and sold by Merck as Vioxx. Dr. Graham also said that studies on the safety and efficacy of the drug are neither adequate nor reasonable to support its approval. Experts also said that Arcoxia may substantially increase the risk of stroke and heart attacks, but is no more effective for pain relief than other NSAIDs. Merck defended its drug and the safety studies, emphasizing that there is more long term data for this drug than many others. They stated that they believe that the drug is a valuable treatment for osteoarthritis.
As a side note, if anyone is keeping track of the Vioxx cases, Merck is now 10-5. The company policy has been to fight each Vioxx trial individually, which it can afford to do with the billions of dollars in sales it brings in every year. Before Merck pulled Vioxx from the market, the sales of the drug averaged over $2 billion a year.
Published On: April 15, 2007