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AMGEN FILES WITH FDA FOR USE OF KINERET(R) TO INHIBIT BONE AND JOINT DAMAGE DUE TO RHEUMATOID ARTHRITISTHOUSAND OAKS, Calif., October 22, 2002 - Amgen (NASDAQ: AMGN) today announced that it has submitted a supplemental Biologics License Application (sBLA) with the U.S. Food and Drug Administration (FDA) for the use of Kineret (R) (anakinra) to inhibit the progression of structural damage in adult patients with moderately to severely active rheumatoid arthritis (RA).
"This study provides evidence that inhibition of the inflammatory protein interleukin-1 slows the progression of RA,” said Dr. Pirow Bekker, Amgen senior director of clinical research. “In a one-year study, we found that more patients treated with Kineret had no progression in bone erosions or cartilage degradation than patients treated with placebo. We also saw that the effect of Kineret was evident early, with significant inhibition of disease progression apparent by week 24.”
The sBLA is based on the results of a 12-month, double blind, placebo controlled trial. The study results will be presented in a late breaking poster session at the 66th Annual American College of Rheumatology Scientific Meeting in New Orleans.
Kineret is the only approved therapy that directly and selectively blocks interleukin-1 (IL-1), a protein present in excess in RA patients that causes joint inflammation and damage. By blocking IL-1, Kineret inhibits the inflammatory response in RA including pain.
Kineret is part of Amgen's portfolio of therapies to treat rheumatoid arthritis.
Kineret is indicated for the reduction in signs and symptoms of moderately to severely active RA in patients 18 years of age or older who have failed one or more disease modifying antirheumatic drugs (DMARDs). It can be used alone or in combination with DMARDs, other than Tumor Necrosis Factor (TNF) blocking agents.
The most common side effect seen with Kineret in clinical trials was a reaction at the site of injection, usually mild, characterized by redness, swelling and pain. Also, there was a risk of serious infections (2 percent in Kineret patients vs. less than 1 percent in placebo patients). Although Kineret should be discontinued if a patient develops an infection, most patients can continue taking Kineret after their infection resolves. Kineret should not be used with TNF blocking agents etanercept and infliximab. A 7 percent rate of serious infections was observed in two studies with concurrent administration of Kineret and etanercept.
Amgen is a global biotechnology company that discovers, develops, manufactures and markets important human therapeutics based on advances in cellular and molecular biology.
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Contact: Amgen, Thousand Oaks
Rebecca Hamm, 805/447-3872 (media)
Cary Rosansky, 805/447-4634 (investors)
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