Thursday, September 18, 2008

FDA Issues Complete Response Letter to Roche for Acterma (tocilizumab) Biologics License Application

Roche today announced that the U.S. Food and Drug Administration (FDA) has issued a complete response letter 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).

The details can be read here.

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