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Roche/Biogen Idec ocrelizumab axed in RA

This article was originally published in Pharmaceutical Approvals Monthly

Executive Summary

In an unsurprising development, Roche and Biogen Idec said on May 19 that they are dropping development of the anti-CD20 antibody ocrelizumab in rheumatoid arthritis. The companies had already suspended development of ocrelizumab in RA due to a higher incidence of opportunistic infections, including fatalities, in the 800-patient SCRIPT trial in patients for whom anti-TNF drugs had stopped working (1"The Pink Sheet" DAILY, March 8, 2010). Another trial, FILM, had already been put on clinical hold in 2009 because of the concern. Ocrelizumab is still in a Phase II trial in relapsing multiple sclerosis, and the companies recently said they remain committed to this indication (2"The Pink Sheet," DAILY, March 23, 2010). However, Lazard analyst Joel Sendek said given the safety issues and availability of alternative treatments, its future in MS is also in doubt. "We believe BIIB and its collaborator may not opt to move forward into Phase III in MS unless the Phase II data are overwhelmingly positive," Sendek wrote in a May 19 note

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