ROCHE, Ocrelizumab: Long term safety and efficacy – Gaining confidence in positive Phase III readout

October 2011 | 3 pages | ID: R4EB4E0F8C2EN
MP Advisors

Abstracts

At European Committee of Treatment and Research in Multiple Sclerosis (ECTRIMS) 2011, Roche today announced the long term (96 weeks) safety and efficacy data from a PhII study on ocrelizumab in Relapsing Remitting Multiple Sclerosis (RRMS). The selected dose of ocrelizumab maintained its efficacy and safety profile from 24 wk to 96 wks. There were no cases of opportunistic infection which was the key concern with this drug, as earlier last year; a pivotal clinical study on Ocrelizumab in Rheumatoid Arthritis was discontinued due to increase in opportunistic infection (rate of serious infections - 3.54 and 8.66 per 100 patient year in the 200mg and 500mg doses). Cross trial efficacy and safety comparison of marketed and pipeline drugs in multiple sclerosis were analysed.

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