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May 19, 2010

Roche and Biogen Idec Ditch Phase III RA Program with Ocrelizumab

Roche and Biogen Idec Ditch Phase III RA Program with Ocrelizumab

Phase II development of anti-CD20 mAb in multiple sclerosis will continue. [© Laurin Rinder -]

  • Roche and Biogen Idec have decided to ditch further development of Ocrelizumab as a treatment for rheumatoid arthritis (RA). Their decision to stop the Phase III program was based on an analysis of trial data, which suggested that the drug didn’t have a satisfactory benefit to risk profile.

    Axing of the RA program comes as no surprise. In March the firms suspended treatment of patients in the RA trials due to concerns about potentially fatal infections. The Ocrelizumab RA program had included four Phase III studies: SCRIPT, FILM, FEATURE, and STAGE.

    In December the companies announced positive efficacy results from the STAGE trial evaluating ocrelizumab in combination with methotrexate. But an analysis by the independent Data and Safety Monitoring Board of all four RA studies revealed a high risk profile for RA patients.

    Clinical studies with the humanized anti-CD20 mAB in lupus nephritis had already been halted due to safety concerns. Roche and Biogen Idec state that they are continuing with Phase II development of ocrelizumab for the treatment of relapsing-remitting multiple sclerosis.

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