Alemtuzumab is a humanized monoclonal antibody used as a potential therapy to treat relapsing-remitting multiple sclerosis.
In the trial, alemtuzumab was given to patients in two or three annual cycles of not more than five days per cycle, while Rebif was given to patients three times per week, every week for three years.
The study included an extended phase for collection of long-term efficacy and safety data.
Results of the five-year review showed an estimated 65% of alemtuzumab treated patients were free of clinically active disease, compared to 27% of patients taking Rebif.
To be free of clinically active disease, MS patients in the trial were both relapse-free and without a sustained increase in disability as measured by the Expanded Disability Status Scale (EDSS) through five years.
The trial showed an estimated 72% of alemtuzumab-treated patients were relapse free compared to 41% of patients taking Rebif; and an estimated 87%of alemtuzumab-treated patients were free of sustained accumulation of disability compared to 62 % of patients taking Rebif which was previously reported.
Two pivotal Phase 3 studies investigating alemtuzumab, CARE-MS I and II, are currently ongoing. Top-line results from these trials are expected to be available respectively early in the third quarter of 2011 and in the fourth quarter of 2011.
The company expects to file for the US and EU approvals in early 2012, and has been granted fast track status by the FDA for this submission.