Federal drug regulators have approved a new medicine for adults with moderate to severe rheumatoid arthritis who have not responded adequately to other treatments. The drug, which will be sold under the name Actemra, was developed by Roche’s subsidiary Genentech. The use of Actemra is limited to a specific group of patients because of serious safety issues observed in clinical studies. The problems observed in patients participating in clinical studies included elevated liver enzymes, hypertension, elevated cholesterol and gastrointestinal perforations.
The Food and Drug Administration is requiring Genentech to conduct a post-marketing clinical trial in order to evaluate Actemra’s long-term safety. Star Ledger.