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| |  FDA Approves Tocilizumab for Rheumatoid Arthritis ROCKVILLE, Md -- January 11, 2010 -- The US Food and Drug Administration has approved tocilizumab (Actemra) to treat adults with moderate to severe rheumatoid arthritis who have not adequately responded to or cannot tolerate other approved drug classes for rheumatoid arthritis. Tocilizumab’s recommended use is limited to patients who have failed other approved therapies because of serious safety concerns that were noted in clinical studies. These safety concerns include elevated liver enzymes, elevated low-density lipoprotein (LDL), hypertension, and gastrointestinal perforations. “Physicians and patients need to be aware of the risk of serious adverse effects of [tocilizumab] and make informed decisions regarding its benefits and risks in the treatment of individual patients,” said Bob Rappaport, MD, Division of Analgesics, Anesthetics and Rheumatology Products, FDA’s Center for Drug Evaluation and Research, Rockville, Maryland. The FDA is requiring the sponsor to conduct a post-marketing clinical trial to further evaluate the long-term safety of tocilizumab. Specifically, the FDA wants to evaluate the impact of elevated LDL cholesterol and blood pressure seen in some patients in shorter-term trials on the cardiovascular health of patients treated with tocilizumab. In addition, a Risk Evaluation and Mitigation Strategy (REMS) will require the drug sponsor to implement a Communication Plan for physicians informing them how to appropriately monitor their patients for liver and/or gastrointestinal side effects. The REMS will include a Medication Guide to ensure that patients are informed of the benefits and risks of tocilizumab. The effectiveness and safety of tocilizumab was determined in 5 clinical trials in adult patients with active rheumatoid arthritis. In all of the trials, patients treated with tocilizumab experienced greater improvement in their tender or swollen joints than patients treated with a placebo. The most common adverse reactions in trials were upper respiratory tract infections, headache, inflammation of the nose or nasal passage, high blood pressure, and increased liver enzymes. Elevations in the LDL were also seen in some patients, some of whom required the addition of lipid lowering agents. Patients treated with tocilizumab are at increased risk for developing serious infections. Most patients who developed these infections in clinical trials were also taking other drugs that suppress the immune system such as methotrexate or corticosteroids.
SOURCE: US Food and Drug Administration
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