Roche receives EU recommendation for RoActemra extension

Roche has received a recommendation for European approval of a new application extension for its rheumatoid arthritis drug RoActemra.

The European Medicines Agency's Committee for Medicinal Products for Human Use has backed the company's efforts to seek approval for the drug as a treatment for active systemic juvenile idiopathic arthritis (sJIA) in patients aged two and above.

Roche hopes to gain ratification for RoActemra in this specification on its own or in combination with methotrexate among those who have failed to respond to previous therapy with NSAIDs and systemic corticosteroids.

The authorisation application was based on positive data from Tender, a phase III trial that demonstrated the safety and efficacy of RoActemra as an sJIA treatment compared to placebo.

A final decision on approval will be taken by the European Commission in July 2011.

Earlier this month, Roche submitted authorisation applications in both the EU and US for vemurafenib, a new treatment option for certain forms of metastatic melanoma.