Arthritis

Updated 11 January 2016

Actemra Approved for Rheumatoid Arthritis

For people who haven't responded to other RA drugs

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Actemra (tocilizumab) has been approved by the U.S. Food and Drug Administration to treat rheumatoid arthritis among people who haven't responded to, or who cannot tolerate, other approved rheumatoid arthritis drugs, the agency said Monday.

Actemra was approved for limited use because of adverse reactions noted in clinical trials, including the possibility of elevated liver enzymes, elevated "bad" cholesterol (LDL), hypertension, and gastrointestinal perforations, the agency said in a news release.

Actemra blocks an immune system protein called interleukin-6, which is found in excess in people with rheumatoid arthritis.

As a condition of the approval, San Francisco-based Genentech, the drug's marketer, must conduct additional clinical studies to evaluate the drug's long-term effectiveness and cardiovascular safety, the FDA said.

The agency said it also is requiring development of a Risk Evaluation and Mitigation Strategy for doctors, to inform physicians on how to monitor patients for possible liver or gastrointestinal side effects.

The most common adverse effects found in clinical testing included upper respiratory infections and other "serious" infections, headache, nasal and sinus inflammation, high blood pressure and increased liver enzymes, the agency said.

Read more:

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Chinese herb for rheumatoid arthritis

 

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Professor Asgar Ali Kalla completed his MBChB (Bachelor of Medicine and Bachelor of Surgery) degree in 1975 at the University of Cape Town and his FRCP in 2003 in London. Professor Ali Kalla is the Isaac Albow Chair of Rheumatology at the University of Cape Town and also the Head of Division of Rheumatology at Groote Schuur Hospital. He has participated in a number of clinical trials for rheumatology and is active in community outreach. Prof Ali Kalla is an expert in Arthritis for Health24.

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