Centocor Ortho Biotech seeks expanded approval for Simponi
HORSHAM, Pa. The biotech division of Johnson & Johnson is hoping to expand the use of a treatment for autoimmune disorders.
Centocor Ortho Biotech said it had filed an application with the Food and Drug Administration to get approval for Simponi (golimumab) to stop the progression of structural damage, induce major clinical response, maintain reductions in signs and symptoms, and improve physical function in the treatment of rheumatoid arthritis.
The FDA approved Simponi in April 2009 as a treatment for various forms of arthritis. When used to treat RA, it is combined with the drug methotrexate.