The biologics license application submission is based on results from five international Phase III studies which demonstrated Actemra as monotherapy or in combination with disease modifying anti-rheumatic drugs (DMARDs) such as methotrexate, significantly reduced the signs and symptoms of rheumatoid arthritis as measured by ACR as well as achieving disease activity score remission compared to DMARD therapies alone. Furthermore, patients who had previously failed anti-tumor necrosis factor treatments also showed significant improvement in signs and symptoms of rheumatoid arthritis (RA) after treatment with Actemra.
Roche will file a marketing authorization application for Actemra with the European Medicines Agency in early December. Actemra is the first humanized interleukin-6 (IL-6) receptor-inhibiting monoclonal antibody and represents a novel mechanism of action to treat RA.
George Abercrombie, president and CEO of Hoffmann-La Roche, said: “The filing for Actemra represents a significant milestone for Roche, and brings us another step closer to making this important therapy available to the millions of patients in the US who suffer from the agonizing pain and debilitating effects associated with rheumatoid arthritis.”