FDA Approves Actemra for Treatment of Rheumatoid Arthritis
Yesterday, Genetech Inc (a subsidiary of the Roche Group) announced that the U.S. Food and Drug Administration (FDA) has approved Actemra (tocilizumab) for the treatment of moderately to severely active rheumatoid arthritis (RA) in adult patients. These patients must have had an inadequate response to one or more tumor necrosis factor (TNF) antagonist therapies before Actemra can be used.
Actemra is the first interleukin-6 (IL-6) receptor-inhibiting monoclonal antibody to gain approval by the US FDA for treatment of RA. The drug has alreadybeen approved for use in Europe and Japan. Actemra may be used alone or in combination with methotrexate or other disease modifying anti-rheumatic drugs (DMARDs).
Actemra has been studied in five multi-national Phase III studies, involving more than 4,000 patients. The studies showed that Actemra used alone or in combination with methotrexate or other DMARDs significantly reduced RA signs and symptoms compared with DMARDs alone. Actemra reduces the activity of IL-6, one of several key cytokines involved in the inflammatory process, reducing both inflammation of the joints and certain systemic symptoms of RA.
Actemra has been approved for once-a-month intravenous administration in doctors' offices, hospitals and infusion centers. It may be used alone or in combination with methotrexate or other DMARDs. The recommended starting dose of Actemra is 4 mg/kg in patients who have had an inadequate response to one or more TNF antagonists. The dose may then be increased to 8 mg/kg based on clinical response.
Actemra’s approval comes with a Risk Evaluation and Mitigation Strategy (REMS) that includes a medication guide, communication plan and timetable for submission of assessments. The drug becomes available the week of January 18, 2010.
Serious side effects include serious infections that may lead to hospitalization or death, gastrointestinal perforations (a hole in the stomach or intestines), and hypersensitivity reactions including anaphylaxis. Treatments that suppress the immune system, such as Actemra, may cause an increase in the risk of cancer. For additional important safety information, including Boxed WARNINGS and Medication Guide, please visit http://www.actemra.com or call 1-800-ACTEMRA (228-3672).
According to the Arthritis Foundation, RA affects approximately 1.3 million adults in the United States. RA is a progressive, systemic autoimmune disease characterized by inflammation of the membrane lining in the joints. Characteristics of RA include redness, swelling, pain and movement limitation around joints of the hands, feet, elbows, knees and neck that leads to loss of function.