Humira RA labeling expansion
This article was originally published in Pharmaceutical Approvals Monthly
Executive Summary
Abbott's Humira (adalimumab) label was updated to reflect new data that the monoclonal antibody inhibits irreversible joint damage in patients with rheumatoid arthritis for up to five years. A five-year study conducted in patients with long-standing RA demonstrated that roughly 60 percents of patients showed no radiographic progression after five years. Patients with inadequate response to methotrexate received adalimumab plus methotrexate to evaluate radiographic disease progression and safety of the therapy...