FDA issues complete response letter to Roche for Actemra Biologics License Application

No new clinical studies requested

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 moderate to severe rheumatoid arthritis (RA).

Additional information requested by the FDA for approval does not involve safety or efficacy issues, nor do any additional studies need to be conducted as a pre-requisite for approval of Actemra. The FDA has requested additional documentation related to the manufacturing of Actemra and certain other outstanding components such as final labelling. Roche is committed to working with the FDA to promptly address these outstanding matters. Upon satisfactory completion of the FDA’s requests and an approved label, Roche does not foresee any issues that would impact the quality, availability and supply of Actemra in the U.S.

“Roche is committed to making this important new therapy available to RA patients,” said William M. Burns, CEO of Roche’s Pharmaceutical Division. “We will continue to work closely with the FDA to address its questions and define the path forward for Actemra. We are confident that we will be able to resolve these matters with the agency in the near future.”

Roche submitted the BLA for Actemra to the agency on November 26, 2007. The BLA for Actemra included results from five multi-national Phase III studies, which demonstrated that treatment with Actemra - alone or in combination with methotrexate or other disease modifying anti-rheumatic drugs (DMARDs) - significantly reduced RA signs and symptoms, regardless of previous therapy or disease severity, compared with current DMARDs alone. On July 29, 2008, the Arthritis Advisory Committee of the FDA voted 10-1 to recommend approval of Actemra. Actemra has also been filed with the European authorities and other world authorities.