FDA Panel Wants Arthritis Drug Approved
Wednesday, September 7th 2005, 9:58 am
By: News On 6
WASHINGTON (AP) _ A Food and Drug Administration advisory committee on Tuesday recommended approval for a new drug to treat rheumatoid arthritis, a sometimes disabling condition that affects an estimated 2.1 million Americans, most of them women.
The drug, abatacept, designed to be given intravenously, suppresses part of the immune system. Manufacturer Bristol-Myers Squibb is recommending it as an alternative for patients who do not respond to existing treatments.
During a hearing, the FDA's Arthritis Advisory Committee voted 7-0 that the benefits of the drug outweigh any risks.
Abatacept will sell under the trade name Orencia if it gets FDA approval. The agency isn't required to follow the recommendations of its advisory committees, though it generally does so.
Rheumatoid arthritis happens when the linings of joints become inflamed after the body's immune system mistakenly acts against them. Joints become swollen and painful.
Treatments for rheumatoid arthritis typically involve immunosuppressants. Abatacept uses a new mechanism, blocking the activation of T-cells, which play a role in the body's immune response.
In tests, patients who took the drug reported less pain and increased ability to function.
As with other drugs that affect the body's immune system, concerns about abatacept include increased risk for infections or cancer. Some studies of the drug showed a higher rate of occurrence of certain infections compared with a group taking a placebo.
Bristol-Myers Squibb also outlined a plan to conduct unusually extensive follow-up studies on patients taking the drug.