Roche receives EU approval for subcutaneous version of RoActemra

Roche has announced that its rheumatoid arthritis drug has been approved in a new subcutaneous formulation by the European Commission.

The drug becomes the first anti IL-6 receptor biologic available for subcutaneous and intravenous administration in both monotherapy and combination therapy applications for the treatment of moderate to severe rheumatoid arthritis.

Data from the phase III Summacta and Brevacta studies – which showed the efficacy and non-inferiority of the new subcutaneous method compared to the established intravenous pathway – helped to support this approval.

This is the fourth update to RoActemra's European label and significantly expands the number of patients who now have access to the drug.

Dr Sandra Horning, head of global product development and chief medical officer at Roche, said: "Together with their physicians, patients can choose whether to self-inject RoActemra at home or have it administered in their doctor's office."

During the first quarter of 2014, the company achieved a five percent year-on-year growth rate, with sales of RoActemra shown to be one of the key drivers of growth.