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Genentech Submits Actemra sBLA

New indication for RA biologic

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By: Tim Wright

Editor-in-Chief, Contract Pharma

Genentech has submitted a sBLA to the FDA for Actemra for the prevention of structural joint damage (as assessed by radiograph) and improvement in physical function in adults with moderately to severely active rheumatoid arthritis (RA). Actemra was approved by the FDA on January 8, 2010 as the first interleukin-6 (IL-6) receptor-inhibiting monoclonal antibody to treat RA in adult patients after an inadequate response to at least one other medicine called a tumor necrosis factor (TNF) antagonist....

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