FDA Approves MAb for Rheumatoid Arthritis
The US Food and Drug Administration has approved Genentech's Actemra (tocilizumab) to treat adults with moderate to severe rheumatoid arthritis who have not adequately responded to or cannot tolerate other approved therapies for rheumatoid arthritis.
The US Food and Drug Administration has approved Genentech’s Actemra (tocilizumab) to treat adults with moderate to severe rheumatoid arthritis who have not adequately responded to or cannot tolerate other approved therapies for rheumatoid arthritis.
Actemra works by blocking the action of interleukin-6, an immune system protein that is overabundant in people with rheumatoid arthritis.
The FDA is requiring the sponsor to conduct a postmarketing clinical trial to further evaluate the long-term safety of Actemra. 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 or gastrointestinal side effects. The REMS will include a medication guide to ensure that patients are informed of the benefits and risks of Actemra.
Actemra’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) or bad cholesterol, hypertension, and gastrointestinal perforations.
Genentech Inc., is a subsidiary of the Roche Group.
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