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Genzyme's Lemtrada shows five-year efficacy in extended trials

Published on 08/10/15 at 09:59am

Sanofi’s subsidiary Genzyme has achieved positive data from an extension study of Lemtrada in patients with relapsing remitting multiple sclerosis (RRMS).  

The studies compared treatment with Lemtrada (alemtuzumab) with high-dose subcutaneous interferon beta-1a (Rebif). 

In the extension of two, two-year Phase III studies, people treated with Lemtrada continued to have low relapse rates after that were maintained for three additional years in the extension study.  

The low annual relapse rates observed in patients who received Lemtrada in the original studies – CARE-MS I (0.18) and CARE-MS II (0.27) – were maintained from year three (0.19 and 0.22) to year five (0.15 and 0.18). 

Through year five, 80% and 76% of patients who received Lemtrada in CARE-MS I and CARE-MS II, respectively, did not experience worsening of disability progression confirmed over six months as measured by the Expanded Disability Status Scale (EDSS). 

Through year five, 33% and 43% of patients who had some disability before receiving Lemtrada in CARE-MS I and CARE-MS II, respectively, had improvement in their EDSS score confirmed over at least six months as compared with pre-treatment baseline. 

And in each of years three, four and five, most patients had no evidence of MRI disease activity (70 - 72%, CARE-MS I; 68 - 70%, CARE-MS II). 

The results will be presented tomorrow at the 31st Congress of the European Committee for Treatment and Research in Multiple Sclerosis (ECTRIMS) in Barcelona, Spain. 

Professor Eva Havrdová, from the MS Center at the department of neurology at Charles University in Prague comments: "These data illustrate that most Lemtrada patients experienced sustained effects of treatment, despite the absence of additional treatment courses. It is encouraging to see consistent effects maintained across multiple meaningful outcomes through five years." 

The US FDA approved Lemtrada last year having originally rejected the drug due to concerns over the safety profile. It was approved in Europe in 2013. 

Genzyme recommends implementation of risks management programs incorporating education and monitoring help support early detection and manage these key identified and potential risks. 

Despite the safety profile, which means the drug will generally be reserved for patients whose response to two or more drugs has been inadequate, Genzyme hailed the significance of the extended clinical trial results.

Bill Sibold, head of the company’s multiple sclerosis business, says: "The five-year data announced today are exciting and important for people living with relapsing MS, because of Lemtrada's potential to change the treatment approach for patients who continue to suffer from this debilitating disease, and for whom Lemtrada is an option."

Joel Levy 

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