J&J's Once-Monthly Simponi Approved for Three Rheumatic Indications

Centocor Ortho Biotech (Horsham, PA), a subsidiary of Johnson & Johnson, received approval from the US Food and Drug Administration on April 24 for Simponi (golimumbad), a monthly treatment for moderate-to-severe rheumatoid arthritis, active psoriatic arthritis, and active ankylosing spondylitis.

Simponi, which is injected subcutaneously, is the first patient-administered anti-tumor necrosis factor (TNF)-alpha therapy used only once a month. Other TNF drugs, such as Enbrel, marketed by Wyeth and Amgen, and Abbott Laboratories’ Humira, are generally injected once every week or two weeks. The drug is available in two dosage forms, a prefilled syringe and an autoinjector designed to meet the needs of arthritis patients.

Simponi is intended for use in combination with the immunosuppressant drug methotrexate in patients with rheumatoid arthritis. It also may be used with or without methotrexate for psoriatic arthritis and alone in patients with ankylosing spondylitis, a chronic inflammatory arthritis of the spine.

The drug will be co-marketed by Centocor and Schering-Plough. Centocor, which developed the drug, will handle US sales, and Schering-Plough will market the drug in most countries outside the US. The drug is a follow-up to Remicade, which also co-marketed by the two companies.