HORSHAM, Pennsylvania—Centocor Ortho Biotech Inc. announced that the US Food and Drug Administration (FDA) has approved Simponi^® (golimumab) for the treatment of moderately to severely active rheumatoid arthritis (RA), active psoriatic arthritis (PsA), and active ankylosing spondylitis (AS). Golimumab is   the first patient-administered anti-tumor necrosis factor (TNF)-alpha therapy to offer once-monthly treatment.

The FDA required Centocor to develop a Risk Evaluation and Mitigation Strategy (REMS) for golimumab to assure safety equivalent to other drugs in this class. The REMS includes a medication guide for patients and a communication plan to educate physicians about risks. The monthly subcutaneous injection will also carry a boxed warning on the risk of tuberculosis and invasive fungal infection associated with golimumab and other TNF inhibitors.

The drug, which is given subcutaneously and used in conjunction with methotrexate (MTX), was approved earlier this month by Health Canada for the same 3 indications.

"Simponi has been studied in a broad range of patients with rheumatoid arthritis, psoriatic arthritis, and ankylosing spondylitis who had previously received a wide variety of treatments, including adults with rheumatoid arthritis previously treated with anti-TNF therapies, and has been shown to be significantly effective in reducing the signs and symptoms of each of these diseases," said Jonathan Kay, MD, Associate Clinical Professor of Medicine, Harvard Medical School and lead study investigator. "The approval of Simponi offers rheumatologists an effective new anti-TNF therapy for patients living with rheumatic diseases."

In the US, Simponi is approved as a 50-mg subcutaneous injection once a month and is indicated in combination with methotrexate for the treatment of adult patients with moderately to severely active rheumatoid arthritis; alone or in combination with methotrexate for the treatment of adult patients with active psoriatic arthritis; and for the treatment of adult patients with active ankylosing spondylitis.

Simponi efficacy and safety were evaluated in simultaneous studies in rheumatoid arthritis, psoriatic arthritis, and ankylosing spondylitis, which included more than 2,000 patients across five pivotal Phase 3 trials. In each of the three trials, significantly more patients receiving Simponi 50 mg plus methotrexate achieved at least a 20 percent improvement in arthritis symptoms (ACR20), compared with patients receiving placebo plus methotrexate and/or other disease modifying anti-rheumatic drugs. Improvements were seen as early as 4 weeks after the first Simponi injection and continued to increase over time.

"The approval of new and effective treatment options is always good news for the arthritis community, as not all patients respond the same to currently available treatment options," said Dr. John Hardin, Chief Scientific Officer for the Arthritis Foundation. "Anti-TNF agents have become an important advancement in the treatment of rheumatoid arthritis, psoriatic arthritis, and ankylosing spondylitis, and each approval offers physicians and patients yet another option within this important class of therapy."