FDA Advisory Committee Recommends Approval of Amgen's Kineret for the Treatment of Rheumatoid Arthritis

Business Wire, August 16, 2001

Business Editors and Health Writers

THOUSAND OAKS, Calif.--(BUSINESS WIRE)--Aug. 16, 2001

Amgen (Nasdaq:AMGN) today announced that the U.S. Food and Drug Administration (FDA) Arthritis Advisory Committee has recommended that the FDA approve Kineret(TM) (anakinra), a biologic therapy, for the reduction in signs and symptoms of active rheumatoid arthritis (RA).

If approved, Kineret would be the first drug to directly and selectively block interleukin-1 (IL-1), a protein present in excess in RA patients that results in inflammation and joint damage. Kineret is a nearly identical copy of a naturally occurring protein known as interleukin-1 receptor antagonist (IL-1ra).

"The committee's favorable vote is a significant step toward bringing this important therapy to patients who are suffering from the debilitating effects of rheumatoid arthritis," said Dr. Roger M. Perlmutter, Amgen's executive vice president of research and development.

The nearly 3,000 patient worldwide clinical trial program was the largest ever conducted for a biologic rheumatoid arthritis medicine prior to commercialization. Five randomized, double-blind, placebo-controlled trials have been conducted to evaluate the safety and effectiveness of Kineret when used alone or in combination with other disease modifying anti-rheumatic drugs in improving the signs and symptoms of rheumatoid arthritis as measured by American College of Rheumatology (ACR) criteria and joint destruction as measured by the Larsen score.

Kineret has been studied in a broad range of patients with varying degrees of disease severity and in combination with a variety of other treatments prescribed for RA. The most frequent treatment-related adverse events reported were mild to moderate injection-site reactions.

The FDA's 32 advisory committees provide independent opinions and recommendations to the Agency on applications to market new drugs. Advisory committees consist of medical professionals, scientists and researchers who are recognized as experts in their fields, as well as industry leaders, consumer representatives and patient representatives. Marketing applications include data to show the safety and effectiveness of human drugs. The committees receive summary information about the applications and copies of the Agency's review of the application documents. Based on this information, advisory committees may recommend approval or disapproval of a drug's marketing application, or ask for more information. Although the committees provide recommendations to the Agency, final decisions are made by the FDA.

Rheumatoid arthritis is the most serious and disabling type of arthritis, affecting more than 2.1 million Americans. It is an autoimmune disease, meaning that the body's immune system does not function properly and attacks healthy joint tissue as it would foreign cells. The total direct costs for RA are estimated to be nearly $5 billion annually in the United States.(a)

Amgen is a global biotechnology company that discovers, develops, manufactures and markets important human therapeutics based on advances in cellular and molecular biology.

EDITOR'S NOTE: An electronic version of this news release may be accessed via our Web site at www.amgen.com. Visit the Corporate Center and click on Amgen News. Journalists and media representatives may sign up to receive all news releases electronically at time of announcement by filling out a short form in the Amgen News section of the Web site.

Interleukin-1.com is the first Web site with the latest scientifically rigorous clinical data regarding IL-1 in RA. The Web site consists of access to published materials, including relevant articles and abstracts, plus the latest version of the popular "Proinflammatory and Anti-Inflammatory Cytokines in Rheumatoid Arthritis: A Primer for Clinicians."

(a) Birnbaum HG, Barton M, Greenberg PE, et al. Direct and indirect costs of rheumatoid arthritis to an employer. J Occup Environ Med. 2000;42(6):588-596.