Roche announced that it has received approval from the European Commission for its new subcutaneous formulation of RoACTEMRA (tocilizumab) for patients with moderate to severe rheumatoid arthritis that are intolerant or have failed to respond to other RA treatments.
The European approval makes RoActemra the first anti IL-6 receptor biologic available as subcutaneous and intravenous (IV) formulations for both monotherapy and combination therapy with methotrexate (MTX). Roche said this is the fourth update to the drug’s European label and expands the number of patients who can access RoActemra.
Sandra Horning, Head of Global Product Development and CMO at Roche, said, “Today’s European approval of RoActemra is important because it provides physicians and patients with the flexibility to choose a treatment method that suits their needs. Together with their physicians, patients can choose whether to self-inject RoActemra at home or have it administered in their doctor’s office.”
Rheumatoid arthritis is an autoimmune disease that affects approximately 40 million around the world. The disease causes joints to become chronically inflamed, swollen, and painful. Patients with RA can become increasingly disabled as bone and cartilage are damaged. Standard treatments for RA include combination of protein-based biologic therapies with MTX, the most common disease modifying anti-rheumatic drug (DMARD).
RoACTEMRA is the first humanized interleukin 6 (IL-6) receptor-antagonist monoclonal antibody approved for use in combination with or without methotrexate. The drug is intended to treat patients with moderate to severe RA that are intolerant or that had inadequate responses to previous therapy with one or more DMARDs or tumor necrosis factor (TNF) antagonists.
The new approval was supported by data from the Phase III trials SUMMACTA and BREVACTA, where the drug demonstrated non-inferiority and long-term efficacy. The subcutaneous formulation of RoACTEMRA was earlier approved in Japan and in the U.S., and will be available via a prefilled syringe.