Sanofi’s Lemtrada beats Rebif in new study
pharmafile | November 14, 2011 | News story | Research and Development, Sales and Marketing | Lemtrada, Rebif, Sanofi
Lemtrada has beaten Merck Serono’s multiple sclerosis treatment Rebif in a new head-to-head trial, paving the way for regulatory submission early next year.
The results of the Phase III study showed that relapse rates and worsening of disability were significantly reduced in multiple sclerosis patients receiving Lemtrada (alemtuzumab) as compared with Merck Serono’s Rebif (interferon beta-1a).
This study builds on several earlier Phase III head-to-head trials that also saw Sanofi’s drug best Rebif.
In the CARE-MS II study, 840 patients treated with Lemtrada 12mg showed a 49% reduction in relapse rates compared to interferon beta-1a, over two years of study.
There was also a 42% reduction in the risk of sustained accumulation (worsening) of disability as measured by the expanded disability status scale.
Sanofi and partner for the drug Bayer, said the results for both of these co-primary endpoints were ‘highly statistically significant’.
The drug is already licensed to treat certain blood cancers under the brand name Campath, and was originally developed by US biotech Genzyme.
The results are big news for Sanofi, which based its $20 billion purchase of Genzyme on the drug’s potential.
David Meeker, the new president and chief executive Genzyme, said that based on these positive results the firm is “on track to submit Lemtrada for review to US and European regulatory authorities in the first quarter of 2012”.
Dr Jeffrey Cohen, a member of the steering committee overseeing the study, said: “The superior efficacy results for alemtuzumab, particularly the slowing of disability, are very promising since this was a head-to-head comparison trial with high dose subcutaneous interferon beta-1a.
“These results suggest alemtuzumab’s potential to offer patients with MS a new and effective treatment option.”
Ben Adams
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