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Neoral Recommended by FDA for Rheumatoid Arthritis EAST HANOVER, N.J., Feb. 4, 1997 -- A Food and Drug Administration (FDA) advisory committee chaired by Dr. Michelle Petri, M.D., M.P.H., Associate Professor of Medicine, Division of Rheumatology at The Johns Hopkins University School of Medicine, today recommended that the FDA approve Novartis' application (filed by Sandoz Pharmaceuticals) to have Neoral(R) (cyclosporine for micro-emulsion) indicated for treatment of severe rheumatoid arthritis. Neoral is currently indicated as an immunosuppressive agent to prevent organ rejection in kidney, liver and heart transplants. During the meeting, the committee heard presentations from members of Novartis' medical and regulatory staffs on the safety and efficacy of the use of Neoral in severe active rheumatoid arthritis. In addition, the company presented data that demonstrated a statistically significant clinical benefit for patients who received both Neoral and methotrexate after having an inadequate clinical response to methotrexate alone. Following presentations by FDA personnel and a committee discussion, the panel voted to endorse the company's request to have Neoral indicated for use in patients with severe active rheumatoid arthritis as well as in combination with methotrexate for rheumatoid arthritis. The patient population eligible for the concomitant therapy would be patients with severe active rheumatoid arthritis in whom at least two slow-acting, second-line drugs or methotrexate are ineffective or not tolerated. The committee also voted for approval for polyarticular juvenile rheumatoid arthritis under the "pediatric rule." Final approval of the new indication is dependent upon the FDA's acceptance of the committee's recommendations. Novartis Pharmaceuticals Corporation is a division of Novartis AG that researches, develops, manufactures and markets leading innovative prescription drugs used to treat a number of diseases and conditions, including organ transplantation, cardiovascular diseases, schizophrenia, cancer, epilepsy and arthritis. As a result of the merger between Ciba Geigy and Sandoz, Novartis AG is now the second largest pharmaceutical business in the world. E-mail this page to a friend or colleague! To print, use this version