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Genentech: FDA Approves Expanded Indication For Actemra In Rheumatoid Arthritis

10/12/2012 11:45 AM ET

Genentech Inc., a member of the Roche Group (RHHBY.PK), announced that the U.S. Food and Drug Administration or FDA has expanded the approved indication for Actemra or tocilizumab for the treatment of adults with moderately to severely active rheumatoid arthritis or RA who have had an inadequate response to one or more disease-modifying antirheumatic drugs or DMARDs.

The company noted that Actemra can be used both alone as a single-agent therapy and in combination with methotrexate or MTX or other Dmards. The expanded indication further supports the safety and efficacy profile of Actemra.

Rheumatoid arthritis (RA) is an autoimmune disease estimated to affect up to 70 million people worldwide, including children. Joints become chronically inflamed, painful and swollen, and patients can become increasingly disabled as cartilage and bone is damaged.

Actemra is the first humanized IL-6 receptor-inhibiting monoclonal antibody approved for the treatment of adult patients with moderately to severely active RA who have had an inadequate response to one or more disease-modifying antirheumatic drugs or DMARDs. In addition, Actemra is also approved for the treatment of active Systemic Juvenile Idiopathic Arthritis (SJIA) in patients two years of age and older.

The company said that some people have serious infections while taking Actemra, including tuberculosis, and infections caused by bacteria, fungi, or viruses that can spread throughout the body. Some people have died from these infections. Common side effects with Actemra in rheumatoid arthritis include upper respiratory tract infections (common cold, sinus infections), headache, and increased blood pressure (hypertension).

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by RTT Staff Writer

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