FDA panel recommends Amgen's Kineret

In a lukewarm display of support for AMGN's Kineret anakinra, FDA's Arthritis Advisory Committee on Thursday voted 6-2 with one abstention to recommend approval of the agent to treat rheumatoid arthritis in adults. Most panel members described the drug's effect on RA as "modest," especially in comparison to recently approved therapies such as Enbrel etanercept, a soluble TNF receptor from Immunex (IMNX). Kineret is an IL-1 receptor antagonist.

With respect to safety data, panel members who voted for Kineret said they did not think the profile was any worse than that of many disease-modifying anti-rheumatic drugs (DMARDs) already marketed for RA. However, one study examining the safety of Kineret in combination with Enbrel did raise eyebrows. FDA reported that 4 serious infections occurred among 58 patients enrolled, a rate of 7%. Panel members cautioned that the RA community is likely to use Kineret in combination with other DMARDs, including TNF blockers. They expressed concern that the trial, which had no placebo arm, was not designed to show efficacy and suggested the possibility of safety issues related to the combination. ...