FDA Denies Approval of Merck Arthritis Pain Medication
On April 12, the Food and Drug Administration panel reviewing Merck & Co's application to market a new drug, Arcoxia (etoricoxib), recommended disapproving the application by a resounding 20-1 vote.
Does this result demonstrate that our system for testing the safety and efficacy of drugs is effective?
Arcoxia is in the same class of compounds as Vioxx. Remember Vioxx? Merck voluntarily removed Vioxx from the market in 2004 following publicity surrounding a number of deaths blamed on the drug. Merck is now defending itself against lawsuits brought by numerous affected individuals and their families.
In November 2006, Merck published the findings of a large clinical trial which it portrayed as demonstrating Arcoxia to be essentially equivalent to the most frequently prescribed drug for chronic arthritis pain, diclofenac, in effectiveness and in side effects. According to Merck, its drug had fewer gastrointestinal side effects, which it argued should make Arcoxia preferable and worth marketing.
The FDA panel, however, found that the reduced gastrointestinal side effects and its ability to relieve pain were overshadowed by cardiac side effects. Its findings, which are not binding on the FDA, will be considered as the FDA issues its final determination, expected soon.
If the vote were closer to even, rather than overwhelmingly against approval, the costs of the testing and analysis might be worthwhile. Such extensive review may not seem reasonable when it seemed so clear to the FDA's experts that the drug was just too risky to allow on the market.
And what about the thousands of participants in the clinical trials of Arcoxia? Have their contributions been for nothing? Maybe not, since patients will not be subjected to the drug's side effects.
As for Merck, its stock jumped 8% overnight, following the release of the FDA panel's recommendations on April 13. It seems that Merck's Friday the 13th announcement of good first quarter profits far overshadowed Arcoxia's apparent obituary in the minds of investors.
In the meantime, let's see what the FDA's final decision on Arcoxia turns out to be.
~Joe
Update: On April 27, Merck announced that the FDA has rejected Merck's application to market Arcoxia.
Related Topics: Technorati Tags: Arcoxia, etoricoxib, Vioxx, Merck, FDA, clinical trials, pain, arthritis, health-and-wellness
Does this result demonstrate that our system for testing the safety and efficacy of drugs is effective?
Arcoxia is in the same class of compounds as Vioxx. Remember Vioxx? Merck voluntarily removed Vioxx from the market in 2004 following publicity surrounding a number of deaths blamed on the drug. Merck is now defending itself against lawsuits brought by numerous affected individuals and their families.
In November 2006, Merck published the findings of a large clinical trial which it portrayed as demonstrating Arcoxia to be essentially equivalent to the most frequently prescribed drug for chronic arthritis pain, diclofenac, in effectiveness and in side effects. According to Merck, its drug had fewer gastrointestinal side effects, which it argued should make Arcoxia preferable and worth marketing.
The FDA panel, however, found that the reduced gastrointestinal side effects and its ability to relieve pain were overshadowed by cardiac side effects. Its findings, which are not binding on the FDA, will be considered as the FDA issues its final determination, expected soon.
If the vote were closer to even, rather than overwhelmingly against approval, the costs of the testing and analysis might be worthwhile. Such extensive review may not seem reasonable when it seemed so clear to the FDA's experts that the drug was just too risky to allow on the market.
And what about the thousands of participants in the clinical trials of Arcoxia? Have their contributions been for nothing? Maybe not, since patients will not be subjected to the drug's side effects.
As for Merck, its stock jumped 8% overnight, following the release of the FDA panel's recommendations on April 13. It seems that Merck's Friday the 13th announcement of good first quarter profits far overshadowed Arcoxia's apparent obituary in the minds of investors.
In the meantime, let's see what the FDA's final decision on Arcoxia turns out to be.
~Joe
Update: On April 27, Merck announced that the FDA has rejected Merck's application to market Arcoxia.
Related Topics: Technorati Tags: Arcoxia, etoricoxib, Vioxx, Merck, FDA, clinical trials, pain, arthritis, health-and-wellness
1 Comments:
william matthews is sueing celibrex company for heath related problems from celibrex. but in recent decovers i have found out he has not takin but in fact has sold them to other people. and he is a hypocondract and nothing is wrong with him and he is just trying to take the company money. thank you for taking this in to concidertion.
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