Roche is celebrating the news that European regulators have given the green light to its new rheumatoid arthritis drug, RoActemra.

The approval was expected seeing as how the European Medicines Agency’s Committee for Medicinal Products for Human Use issued a positive opinion on RoActemra (tocilizumab), combined with methotrexate, in November. The approval covers the treatment of adults with moderate to severe rheumatoid arthritis who do not respond to disease modifying anti-rheumatic drugs (DMARDs) or tumour necrosis factor (TNF) antagonists.

Roche noted that RoActemra is the first interleukin-6 receptor-inhibiting monoclonal antibody developed for the treatment of RA. William Burns, head of the Basel-based group’s pharmaceuticals division, believes the potential for the drug, sold elsewhere as Actemra, is considerable as “many patients suffering from RA fail to respond to any treatment and few actually achieve lasting remission”. He added that Roche will work with the authorities in European Union member countries “to ensure that this groundbreaking therapy will be available to patients as quickly as possible.”

The positive response to tocilizumab in Europe has not been mirrored in the USA. Last month, the Food and Drug Administration said that “based on the evolving requirements for approval of new biologics”, it has asked Roche for non-clinical animal model data, beyond what was included in the Biologics License Application for Actemra. The agency’s Arthritis Advisory Committee voted 10-1 for approval of the drug at the end of July.

Roche, which expects to submit the complete response for Actemra to the FDA in the third quarter of 2009, noted that the drug is approved in Japan, where it is sold by Roche partner Chugai, India and Switzerland.