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Roche and FDA Agree on Pathway Towards U.S. Approval of ACTEMRA(R) (tocilizumab)
Date:12/3/2008

NUTLEY, N.J., Dec. 4 /PRNewswire/ -- Roche today 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(R) (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).

As a result of the FDA's evolving Risk Evaluation and Mitigation Strategy (REMS) requirements for medications, the Agency has clarified that a REMS plan is required to help ensure that health care professionals prescribe and administer ACTEMRA correctly, and that patients understand the potential benefits and risks associated with this medication. Additionally, based on the evolving requirements for approval of new biologics, the FDA has asked Roche for non-clinical animal model data, beyond what was included in the ACTEMRA BLA. Roche is performing the requested pre-clinical studies to confirm the published literature showing that ACTEMRA does not affect peri- and post-natal development, and fertility. The FDA has not requested additional clinical studies prior to approval.

The FDA Office of Compliance has also completed its evaluation of the manufacturing facility in Japan, and has indicated that it is acceptable to manufacture ACTEMRA.

In September, Roche received a complete response letter from the FDA for the ACTEMRA BLA. Since then, Roche has been engaged in productive discussions with the FDA and recently met with Agency representatives for clarification on the outstanding components related to the ACTEMRA BLA.

"Roche will continue to work diligently to fulfill the FDA's requirements, and we anticipate submitting the complete response for ACTEMRA to the Agency in the third quarter of 2009," said George Abercrombie, CEO and president of Roche. "Roche remains confident in t
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