FDA Panel Recommends Approving New Arthritis Drug
FDA Panel Recommends Approving New Arthritis Drug
Aug. 16, 2001 (Washington) -- Rheumatoid arthritis sufferers soon could have a completely new type of drug available to them. A panel of experts convened by the FDA recommended Thursday that this medicine is safe and effective and should be approved.
The drug, which is called Kineret and is given by injection, is a synthetic version of a naturally occurring chemical in the body called interleukin-1 receptor antagonist. This chemical appears to combat other substances that promote the damage seen in rheumatoid arthritis, so by taking Kineret and raising levels of this substance in the body, the pain and joint stiffness associated with the disease should be reduced.
Three clinical trials involving nearly 2,000 patients with rheumatoid arthritis found that more patients receiving Kineret plus other arthritis drugs experienced relief from their symptoms than patients receiving only the other drugs.
Panel members agreed, however, that Kineret appears to be less effective at relieving symptoms than some of the newer arthritis drugs recently made available. Several members justified voting for its approval by noting that Kineret might help patients who fail to improve on the other arthritis therapies.
These types of patients were not included in clinical trials, so there is no data to show whether it will help these patients or not, pointed out Jay Siegel, MD, of the FDA.
Even so, panelist James Williams, MD, of the University of Utah School of Medicine, noted that Kineret is just as effective as some older arthritis drugs that are still in use.
The advisors did express concern that the drug may cause a reduction in infection-fighting white blood cells in some people. They requested that this risk be noted in labeling, as well as a statement to advise doctors that they should monitor for it.
Williams said he thinks the drug is just as safe as current standards of therapy. In addition, "a lot of drugs cause leukopenia, and we're used to monitoring for it," he said.
However, panel member David Felson, MD, of the Boston University School of Medicine, said, "I think the ... safety issues are substantial." Felson voted against approval.
FDA Panel Recommends Approving New Arthritis Drug
Aug. 16, 2001 (Washington) -- Rheumatoid arthritis sufferers soon could have a completely new type of drug available to them. A panel of experts convened by the FDA recommended Thursday that this medicine is safe and effective and should be approved.
The drug, which is called Kineret and is given by injection, is a synthetic version of a naturally occurring chemical in the body called interleukin-1 receptor antagonist. This chemical appears to combat other substances that promote the damage seen in rheumatoid arthritis, so by taking Kineret and raising levels of this substance in the body, the pain and joint stiffness associated with the disease should be reduced.
Three clinical trials involving nearly 2,000 patients with rheumatoid arthritis found that more patients receiving Kineret plus other arthritis drugs experienced relief from their symptoms than patients receiving only the other drugs.
Panel members agreed, however, that Kineret appears to be less effective at relieving symptoms than some of the newer arthritis drugs recently made available. Several members justified voting for its approval by noting that Kineret might help patients who fail to improve on the other arthritis therapies.
These types of patients were not included in clinical trials, so there is no data to show whether it will help these patients or not, pointed out Jay Siegel, MD, of the FDA.
Even so, panelist James Williams, MD, of the University of Utah School of Medicine, noted that Kineret is just as effective as some older arthritis drugs that are still in use.
The advisors did express concern that the drug may cause a reduction in infection-fighting white blood cells in some people. They requested that this risk be noted in labeling, as well as a statement to advise doctors that they should monitor for it.
Williams said he thinks the drug is just as safe as current standards of therapy. In addition, "a lot of drugs cause leukopenia, and we're used to monitoring for it," he said.
However, panel member David Felson, MD, of the Boston University School of Medicine, said, "I think the ... safety issues are substantial." Felson voted against approval.
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