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Roche And FDA Agree On Pathway Towards U.S. Approval Of ACTEMRA® (tocilizumab)

Published December 4, 2008, 9:02 pm, PharmaceuticalOnline

Roche recently announced that the U.S. Food and Drug Administration (FDA) has provided further guidance on the requirements for the Biologics License Application (BLA) for ACTEMRA® (tocilizumab), the first interleukin-6 (IL-6) receptor-inhibiting monoclonal antibody studied for the treatment of adult patients with moderately to severely active rheumatoid arthritis (RA).

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