Thursday, December 4, 2008

Roche and FDA Agree on Pathway Towards U.S. Approval of Actemra (tocilizumab)

Roche today announced that the U.S. FDA has provided further guidance on the requirements for the Biologics License Application 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.

The details can be read here.

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