US FDA rejects broader arthritis use of Janssen Biotech's Simponi
This article was originally published in Scrip
Executive Summary
The US FDA rejected Janssen Biotech's supplemental biologics license application to expand the use of its antitumor necrosis factor (TNF) alpha Simponi (golimumab) as a treatment for inhibiting the progression of structural damage, inducing major clinical response and maintenance of reduction of signs and symptoms and maintenance of improved physical function in patients with moderately to severely active rheumatoid arthritis.