Roche discontinues arthritis drug trials
pharmafile | May 20, 2010 | News story | Sales and Marketing | RA, Roche
Roche and Biogen Idec will discontinue clinical trials for rheumatoid arthritis drug ocrelizumab.
Development of the RA treatment was halted in March amid patient safety concerns. Its cessation followed a recommendation from the independent ocrelizumab RA & Lupus Data Safety Monitoring Board that the safety risk of serious infection outweighed the benefits to the specific patient population.
Roche and Biogen Idec have now concluded the overall benefit-to-risk profile of the RA treatment is not favourable given the other treatment such as Pfizer’s Enbrel, J&J’s Remicade, Abbott’s Humira and Roche’s own MabThera.
Ocrelizumab is an humanised monoclonal antibody that selectively binds to the CD20 antigen protein on the surface of B-cells.
It then interacts with the body’s own immune system to eliminate CD20-positive B-cells, allowing healthy B-cells to regenerate.
The ocrelizumab RA programme included four phase III trials: SCRIPT, FILM, FEATURE and STAGE that will all now be discontinued.
The drug will continue to be evaluated for relapsing remitting multiple sclerosis (RRMS) that is currently in phase II trials. Data from the study will be presented later this year at the ECTRIMS conference.
Hal Barron MD, executive vice president, global development and chief medical officer, Roche, said: “We thank the investigators and patients who participated in the RA clinical studies.
“Although this outcome is disappointing for patients, Roche remains committed to the development of treatments for RA.”
Ben Adams
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