Roche announced Thursday that US regulators asked the company to provide more information on rheumatoid arthritis treatment Actemra (tocilizumab). “We anticipate submitting the complete response for Actemra to the agency in the third quarter of 2009,” stated Jean-Jacques Garaud, Roche’s chief medical officer and head of global pharma development. Roche received an FDA complete response letter for the compound in September.

[ad]

The drugmaker noted that the FDA requested non-clinical animal model data to confirm that the drug does not affect peri- and post-natal development and fertility, and asked that Roche prepare a risk management strategy to ensure that the compound is prescribed properly. The FDA did not request new clinical trials, the company indicated.

Commenting on the news, Collins Stewart analyst James Knight said that “we think Actemra remains highly likely to get US approval.” Rahn & Bodmer’s Birgit Kulhoff, however, suggested that a launch of the product can be expected in 2010 at the earliest.

The drug is already approved in Japan where it is marketed by Chugai, and Roche indicated that SwissMedic approved the product on Wednesday. In November, the compound received a positive opinion in the EU, where, if approved, it would be marketed as RoActemra.

Source: FirstWord

Popularity: 100% [?]