my personal edition > rheumatoid arthritis > news


  E-Mail this DGNews to a colleague

DGNews

FDA Approves Remicade (Infliximab)/Methotrexate Combination to Improve Physical Function in Rheumatoid Arthritis

MALVERN, PA -- February 28, 2002 -- For the first time, the U.S. Food and Drug Administration (FDA) has granted marketing approval for a drug shown to improve physical function in patients with rheumatoid arthritis (RA).

Remicade® (infliximab), in combination with methotrexate, is now the only therapy approved by the FDA to improve physical function, as well as inhibit the progression of structural damage and reduce signs and symptoms in patients with moderately to severely active rheumatoid arthritis who have had an inadequate response to methotrexate therapy alone. Remicade is the worldwide market share leader among tumor necrosis factor alpha (TNF-alpha) therapies and the only biologic drug indicated for the treatment of RA and Crohn's disease, a potentially devastating gastrointestinal disorder.

More than two million Americans are affected by RA, and many c an become disabled from the irreversible joint damage caused by the disease, severely limiting their ability to function -- both in their personal and professional lives. In fact, studies have shown that as many as 50 percent of RA patients experience work disability within a decade of diagnosis.

"According to the American College of Rheumatology's Guidelines for the Management of Rheumatoid Arthritis, the ultimate goal of therapy is to stop disease progression and return patients to normal activity," said David Yocum, M.D., Professor of Medicine, Director, Arizona Arthritis Center. "For the first time we have a therapy that can improve physical function, while positively impacting quality of life activities such as bathing and dressing. This is groundbreaking news for patients and physicians. The results clearly demonstrate that Remicade fulfills a significant unmet medical need in the treatment of RA."

Remicade is a monoclonal antibody that specifically targets and irreversibly binds to TNF-alpha. Overproduction of TNF-alpha is believed to play a role in not only RA and Crohn's disease, but also in a wide range of immune-mediated inflammatory disorders in which Remicade is currently being studied, including ulcerative colitis, psoriasis and spondyloarthropathies, such as ankylosing spondylitis and psoriatic arthritis.

SOURCE: Centocor, Inc.

E-Mail this DGNews to a colleague

To print, use this version