FDA appro for J&J arthritis drug Simponi

Centocor Ortho Biotech, a subsidiary of US health care major Johnson & Johnson, has received Food and Drug Administration approval for  patient-administered anti-tumor necrosis factor-alpha therapy Simponi  (golimumab), indicated as a treatment for moderately-to-severely-active  rheumatoid arthritis, active psoriatic arthritis and active ankylosing  spondylitis.

Simponi is available in both an easy-to-use prefilled syringe and in the  Simponi SmartJect novel auto-injector, designed to meet the needs of  arthritis patients, which has received a commendation from the Arthritis  Foundation.

The approval is based on a program that included more than 2,000  patients across five pivotal Phase III studies. In each of the three  trials, significantly more patients receiving Simponi 50mg plus  methotrexate achieved at least a 20% improvement in arthritis symptoms,  compared with those given placebo plus methotrexate and/or other  disease-modifying anti-rheumatic drugs. Improvements were seen as early  as four weeks after the first Simponi injection and continued to improve  over time. A proportion of patients also achieved substantial  improvements in arthritis symptoms with continued treatment.