This article is part of the Arthritis Archives.
Editor note: Kineret (anakinra) was approved by the United States Food and Drug Administration (FDA) on November 14, 2001.
Dateline: August 19, 2001
Kineret (Anakinra) Approval Recommended
Kineret (anakinra) was recommend for approval by the U.S. Food and Drug Administration Arthritis Advisory Committee on August 16, 2001, by a vote of 6-2-1, for the reduction in signs and symptoms of active rheumatoid arthritis.
Kineret (generic name anakinra), classified as one of the biologic therapies, as is Enbrel (etanercept) and Remicade (infliximab), differs in that it is the first to selectively block interleukin-1 (IL-1). Enbrel and Remicade are both TNF blocker drugs that block tumor necrosis factor (TNF). Interleukin-1 is a protein which is present in excessive amount in patients with rheumatoid arthritis, resulting in inflammation, swelling, pain, and joint damage. Kineret, a genetically engineered version of a natural protein, interferes with the attachment of interleukin-1 to cells and the resulting inflammation.
Committee Concerns
Reportedly, some members of the advisory committee felt Kineret exhibited only "modest" benefit. There also was concern about whether the benefit significantly outweighed the risk of serious infection, a concern which surrounds all of the new biologic drugs.
Kineret Trials
Nearly 3,000 patients participated in the Kineret clinical trial program worldwide. There have been five randomized, double-blind, placebo-controlled trials conducted for the purpose of evaluating the safety and effectiveness of Kineret, when used alone or in combination with other DMARDs (disease-modifying anti-rheumatic drugs). The decision by the advisory committee to recommend approval was based on the results of three clinical studies. About 20 percent more patients receiving Kineret than placebo obtained an improvement in joint swelling and pain.
Side Effects
Kineret is given by daily self-injection under the skin. In the studies, about 50 to 70 percent of Kineret patients experienced injection-site reactions. In one study, serious infections occurred in 2.1 percent of patients on Kineret compared to 0.4 percent of patients receiving placebo.
Amgen originally filed for FDA approval in 1999 but was turned down based on insufficient data. It is expected that the FDA will follow the recommendation of the advisory committee, as it usually does, and that by the end of 2001, Kineret will be approved. The drug, not to be viewed as a cure or magic bullet, will give rheumatoid arthritis patients yet another option to treat the disease. If approved as expected, it has been projected that sales of Amgen's Kineret would tally about $60 million in 2002, and $160 million in 2004.
Related Resources
Sources: FDA Advisory Committee Recommends Approval Of Amgen's Kineret For The Treatment Of Rheumatoid Arthritis, AMGEN News Release, August 16, 2001; Amgen to push for rheumatoid arthritis drug OK, Reuters, August 15, 2001; FDA Panel Endorses Rheumatoid Arthritis Treatment, ReutersHealth, August 16, 2001; US FDA panel backs Amgen arthritis drug Kineret, Reuters, August 16, 2001; FDA Advisers Endorse Arthritis Drug, AP, August 16, 2001
First published: 8/19/2001
