FDA Clears Drug for Rheumatoid Arthritis

Food and Drug Administration (FDA) to inhibit the progression of joint damage in patients with moderately to severely active rheumatoid arthritis who have had an inadequate response to methotrexate.

The approval was based on 54-week data from a two-year trial involving 428 patients at 34 centers in Europe and North America, reported in the November 30 issue of The New England Journal of Medicine. In the trial, patients treated with infliximab in combination with methotrexate were compared to patients treated with methotrexate plus a placebo. A total of 53% of the infliximab patients demonstrated 0% progression, while the methotrexate-only group demonstrated progression comparable to that previously reported. The infliximab patients also reported significantly greater relief from the pain and stiffness of the disease as well as a reduction in the number of swollen and tender joints. Infliximab is the product of Centocor (Malvern, PA, USA).

"The prospect of having a therapy that can actually inhibit the damage caused by rheumatoid arthritis is extremely exciting,” said Virginia Ladd, president and executive director of the American Autoimmune Related Diseases Association, rheumatoid arthritis patients and their doctors will now have a new tool at their disposal for managing this terrible disease.”



Related Links:
Centocor
New England Journal of Medicine