Roche has suffered a setback with the news that regulators in the USA have asked for more data on the potential blockbuster rheumatoid arthritis drug Actemra.

The Swiss major has noted this morning that the Food and Drug Administration has asked for a Risk Evaluation and Mitigation Strategy plan to help ensure that doctors prescribe and administer Actemra (tocilizumab) correctly. Additionally, it noted that “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 Biologics License Application for Actemra.

Roche noted that it 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 Basel-based group stressed that the FDA has not requested additional clinical studies and has passed the manufacturing facility in Japan where Actemra is produced.

This latest setback comes just a few months after the FDA requested additional documentation related to the manufacturing of the drug, a novel interleukin-6 (IL-6) receptor-inhibiting monoclonal antibody, “and certain other outstanding components, such as final labelling”. The agency’s Arthritis Advisory Committee voted 10-1 for approval of Actemra at the end of July.

George Abercrombie, chief executive of the firm’s operations in the USA, said that Roche will “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". The drug is approved in Japan where it is sold by Roche partner, Chugai, and yesterday Swiss authorities gave Actemra the thumbs-up.

Collins Stewart analyst James Knight issued a note saying that Actemra is a potential blockbuster, and as Roche stock “is likely to be weaker today. If so, we’d use it as a buying opportunity”. He added that as the FDA has asked for pre-clinical rather than clinical data, it suggests that “the issues are not serious”.

New European approval for Pegasys
Meantime Roche also noted that the European Commission had approved its hepatitis C drug Pegasys (peginterferon alpha) plus Copegus (ribavirin) for patients who were not successfully treated with an initial course of interferon alpha, either alone or in combination with ribavirin.

"A significant number of patients do not achieve treatment success with their first treatment. This results in a large and growing population of patients who urgently need alternative treatment solutions," Roche said. The latest approval “provides a significantly broader indication for Pegasys and establishes a new standard of care", it added.