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FDA Issues Further Guidance on Tocilizumab Application

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 tocilizumab (Actemra), 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 tocilizumab 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 tocilizumab BLA. Roche is performing the requested pre-clinical studies to confirm the published literature showing that tocilizumab 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 tocilizumab.

In September, Roche received a complete response letter from the FDA for the tocilizumab 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 tocilizumab BLA.

"Roche will continue to work diligently to fulfill the FDA's requirements, and we anticipate submitting the complete response for tocilizumab to the Agency in the third quarter of 2009," said George Abercrombie, CEO and president of Roche. "Roche remains confident in the future of tocilizumab and is committed to making this important new therapy available to patients with RA."

Roche submitted the BLA for tocilizumab to the FDA on November 18, 2007. The BLA for tocilizumab is based on the results of an extensive multi-national clinical development program, which included more than 4,000 patients in 41 countries, including the U.S. These studies demonstrated that treatment with tocilizumab - alone or combination with methotrexate or other DMARDs (disease modifying anti-rheumatic drugs) - significantly reduced RA signs and symptoms, regardless of previous therapy or disease severity, compared with DMARDs alone. On July 29, 2008, the Arthritis Advisory Committee of the FDA voted 10-1 to recommend approval of tocilizumab.

On December 3, 2008, the Swiss authorities approved RoActemra (tocilizumab, known as tocilizumab outside the EU) for the treatment of moderately severe to severe, active rheumatoid arthritis in adult patients who did not respond adequately to treatment with DMARDs or tumor necrosis factor (TNF) inhibitors. RoActemra can be administered as a monotherapy or in combination with methotrexate and/or other conventional DMARDs. There are no significant post-approval commitments required.

On November 21, 2008, Roche announced that the European Committee on Human Medicinal Products (CHMP) provided a positive recommendation for RoActemra. This recommendation is for use of RoActemra in combination with methotrexate for the treatment of adult patients with moderate to severe RA who have either responded inadequately to, or who were intolerant to, previous therapy with one or more DMARDs or TNF antagonists. In these patients, RoActemra can be given as monotherapy in cases of intolerance to methotrexate or where continued treatment with methotrexate is inappropriate.

About Actemra (tocilizumab)
Actemra is the first humanized interleukin-6 (IL-6) receptor-inhibiting monoclonal antibody being studied for the treatment of RA. Studies demonstrate that reducing the activity of IL-6, one of several key cytokines involved in the inflammatory process, relieves both inflammation of the joints and certain systemic effects of RA. The extensive clinical development program conducted by Roche includes five Phase III clinical studies and has enrolled more than 4,000 patients in 41 countries, including the United States. Four Phase III studies are completed and have reported meeting their primary endpoints. A fifth Phase III study, the LITHE study evaluating Actemra in RA is an ongoing two-year study, which is expected to report complete data evaluating the effects of Actemra on the inhibition of structural joint damage in 2009. Actemra is currently under review in the United States and Europe.

Source: Roche

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