FDA greenlights Roche's Actemra
02.05.2013 - Hoffmann La-Roche’s US subsidiary Genentech has gained approval for its IL-6-R blocking arthritis antibody Actemra in children.
Tocilizumab is now authorised for marketing in the US as a treatment of polyarticular juvenile idiopathic arthritis (PJIA). The medicine can be used in children two years of age and older with active disease as a monotherapy or in combination with methotrexate.
Polyarticular juvenile idiopathic arthritis affects approximately 30 in every 100,000 children. The chronic disease is characterised by inflammation in five or more joints within the first six months of the disease and most commonly affects the small joints in the body such as the hands and feet.
The label extension of Roche’s Interleukin-6 receptor antagonist is based on data from the combined open label/double blind Phase III CHERISH study. A total of 91% of patients taking the humanised monoclonal antibody plus methotrexate and 83% of those taking tocilizumab alone achieved an ACR 30 response at week 16 compared to baseline. In the randomized double-blind placebo-controlled withdrawal phase of the trial, 26% of patients in the Actemra arm experienced disease flares compared to 48% in the placebo arm.
Infections, which were in part fatal, were the most common serious adverse events over 40 weeks. Other serious side effects include perforation of the stomach and intestines, changes in blood test results (including low white blood cell count, low platelet count, increase in certain liver function tests, and increase in blood cholesterol levels), hepatitis B infection becoming an active infection again, and nervous system problems. Actemra affects the immune system and may increase a patient's risk of certain cancers.