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FDA releases Kineret analyses

August 15, 2001 7:00 AM UTC

The FDA released on Wednesday its analyses of Amgen's data in support of Kineret anakinra to treat rheumatoid arthritis (RA). FDA concluded that the three efficacy studies submitted by AMGN indicate that the compound is "helpful in reducing the signs and symptoms of rheumatoid arthritis as measured by the ACR20 response." Kineret is an IL-1 receptor antagonist.

In briefing documents that will be considered Thursday at a meeting of the FDA's Arthritis Advisory Committee, the agency noted that in the largest study, "16% more anakinra-treated subjects attained an ACR20 response than patients receiving placebo. A similar effect size was seen with the other two studies at doses in the same range as the dose proposed for marketing (100 mg subcutaneously four times daily). Responses were seen within weeks and were maintained out to 6 months," and effects were seen on all components of the ACR response criteria, according to the FDA. ...