Amgen has submitted a supplemental Biologics License Application (sBLA) with the U.S. Food and Drug Administration (FDA) for the use of Kineret (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.