Amgen's rheumatoid arthritis drug Kineret cleared for marketing in Europe

Amgen's new therapy for rheumatoid arthritis, the interleukin-1receptor antagonist Kineret (anakinra), has been approved for marketing by the European Medicines Evaluation Agency for the treatment of the signs and symptoms of RA, in combination with methotrexate, in patients with an inadequate response to methotrexate alone.

A spokesman for the company told the Marketletter that the product should be rolled out in those countries which do not require reimbursement approval, such as the UK and Germany, within the next few weeks. "The salesforce is ready to go," he commented.

This is a narrower indication than that which was approved in the drug's first market, the USA, last year (Marketletter November 26, 2001). In the latter market, the drug can be given second-line either as a monotherapy or in combination with methotrexate, and the wording refers to the use of any disease-modifying antirheumatic drug as first-line therapy, not just methotrexate.