ça c'était en 2007 ....
WASHINGTON -- A Food and Drug Administration panel of outside medical experts said Thursday the agency should not approve Arcoxia, a Vioxx-like drug by Merck & Co.
The panel voted 20 to 1 against approval of the drug amid concerns it raises the risks of heart attacks and strokes.
The FDA usually follows the advice of its panels but is not required to. The FDA is expected to make a final decision on whether to approve Arcoxia by the end of April.
Arcoxia falls into the same class as Vioxx, which was widely used to treat Merck asked the FDA to approve Arcoxia, a drug that falls into the same class as Vioxx, to treat osteoarthritis. Vioxx was pulled off the market in September 2004 after it was linked to an increased risk of heart attacks and strokes.
David Graham, who works in the FDA's Office of Surveillance and Epidemiology, earlier said if the agency were to approve Arcoxia that it could amount to a "potential public health disaster" and a replay of Vioxx. Mr. Graham outlined his views in a presentation Thursday to the outside panel. Mr. Graham has criticized his agency's handling of Vioxx.
Earlier this week, the FDA said proposed prescription painkillers should fill an unmet medical need for patients who have no other "relatively safer" alternatives, suggesting Arcoxia faces a tough road in getting FDA approval.
Pfizer Inc.'s Celebrex is the only so-called Cox-2 drug on the U.S. market. Cox-2s were designed to be easier on the stomach than older anti-inflammatory drugs, or NSAIDs, which include ibuprofen and naproxen. NSAIDs inhibit the both Cox-2 and Cox-1 enzymes in order to cut pain, however Cox-1 is also related to stomach functioning.
Peter Kim, the president of Merck's research laboratories, said osteoarthritis is an "under-served condition" that's getting worse as the population ages.
"We believe [Arcoxia] represents a valuable treatment option for patients with osteoarthritis," Mr. Kim said. Arcoxia is on the market in more than 60 countries, and Mr. Kim said U.S. patients should have the option to use it as well.
The FDA said it now assumes all prescription nonsteroidal anti-inflammatory drugs, or NSAIDs, which include ibuprofen and naproxen, carry an increased risk of cardiovascular problems. Drugs such as Celebrex and Arcoxia, also fall into the broader NSAID class.
In briefing documents prepared for Thursday's meeting, the FDA said, "a new product that appears to have an increased overall risk profile for CV disease, particularly beyond that seen with other drugs, would not be appropriate for marketing unless the product fills an unmet medical need for a particular patient population that has no relatively safer approved products available to them, and provides a reasonable risk to benefit balance for that population."
John Mack, Editor & Publisher