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Wednesday, May 9, 2012

Alemtuzumab (Campath) Heads for Regulatory Review in MS

Susan Jeffrey
May 7, 2012 (New Orleans, Louisiana) — Full results of a second phase 3 trial of alemtuzumab (Lemtrada, Genzyme/Sanofi) in patients with relapsing-remitting multiple sclerosis (MS) who had relapsed while receiving previous treatment show that the still-investigational treatment met both co-primary endpoints of reductions in relapse rates and sustained accumulation of disability compared with standard therapy with interferon beta-1a (Rebif, EMD Serono/Pfizer).
The findings, from the Comparison of Alemtuzumab and Rebif Efficacy in Multiple Sclerosis 2 (CARE-MS 2) trial, were presented here at the American Academy of Neurology's 64th Annual Meeting. Topline results were released in November 2011 and reported by Medscape Medical News at that time. The study was funded by Genzyme.
"This study shows superior efficacy of alemtuzumab compared to interferon beta-1a across multiple outcomes, including relapses, disability — not only reduced risk of worsening, but increased likelihood of improvement — and on MRI lesion activity and brain volume loss," said Jeffrey Cohen, director of experimental therapeutics, Cleveland Clinic Mellen Center for MS Treatment and Research, Ohio, and a member of the Steering Committee, who presented the results here.
CARE-MS 2 is the third positive study comparing alemtuzumab with an active comparator, interferon beta-1a, "which itself is effective against relapses, disability, and MRI [magnetic resonance imaging]" activity, Dr. Cohen noted. "The adverse event profile was consistent with previous studies, he added, and a program to monitor for development of thyroid issues and immune thrombocytopenia (ITP) was successful in early detection of these known complications.
Alasdair Coles, MD, senior lecturer in the Department of Clinical Neurosciences at the University of Cambridge, United Kingdom (UK), was principal investigator of the CARE-MS 1 trial that compared alemtuzumab with interferon beta-1a in treatment-naive patients. Results of that trial showed a significant reduction in relapse rates at 2 years but no significant effect on sustained accumulation of disability with alemtuzumab.
Dr. Coles told Medscape Medical News that results of these studies now form the basis for a new drug application to the US Food and Drug Administration (FDA) and to the European Medicines Agency (EMA).
Overall, alemtuzumab reduced lesions and delayed or even improved disability and in all trials was compared with active comparator; this, Dr. Coles noted, "has never been done before."
The package of alemtuzumab data is expected to be submitted to the FDA and EMA sometime in the second quarter this year, he said.

Posted by Stuart Schlossman

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