Roche on pathway towards FDA approval of Actemra
The US Food and Drug Administration (FDA) has provided further guidance on the requirements for Roche's Biologics License Application (BLA) for Actemra (tocilizumab), the interleukin-6 receptor-inhibiting monoclonal antibody studied for the treatment of adults with moderately to severely active rheumatoid arthritis.
The US Food and Drug Administration (FDA) has provided further guidance on the requirements for Roche's Biologics License Application (BLA) for Actemra (tocilizumab), the interleukin-6 receptor-inhibiting monoclonal antibody studied for the treatment of adults with moderately to severely active rheumatoid arthritis.
The FDA said a risk evaluation and mitigation strategy is required to help ensure that Actemra is correctly prescribed and administered, and that patients understand the benefits and risks associated with it.
The agency has also asked Roche for more non-clinical animal model data. Roche is carrying out the requested pre-clinical studies to confirm the published literature that shows Actemra does not affect peri- and post-natal development and fertility.
In addition, the FDA Office of Compliance has indicated that the manufacturing facility in Japan is acceptable to manufacture the product.
Jean-Jacques Garaud, chief medical officer and head of global pharma of Roche, said: "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."
Roche submitted the BLA for Actemra to the FDA in November 2007, based on a multi-national clinical development programme that included more than 4,000 patients in 41 countries.