Lemtrada Update: First-of-Its-Kind Treatment for Relapsing-Remitting Multiple Sclerosis Now Available in Canada

MISSISSAUGA, ON, Feb. 27, 2014 /CNW/ – Genzyme, a Sanofi company, today announced the Canadian availability of ^Pr LEMTRADA™ (alemtuzumab) for the management of adult patients with relapsing-remitting multiple sclerosis (RRMS), with active disease defined by clinical and imaging features, who have had an inadequate response to interferon beta or other disease-modifying therapies.

LEMTRADA 12 mg has a dosing and administration schedule of two annual treatment courses. The first treatment course of LEMTRADA is administered via intravenous infusion on five consecutive days, and the second course is administered on three consecutive days, 12 months later. LEMTRADA patients require monitoring at regular intervals between treatment courses and for 48 months following the final infusion.

During an extensive, ongoing clinical development program, 80 per cent of RRMS patients who received two treatment courses of LEMTRADA required no further therapy¹ and 55 per cent remained relapse-free through the first year of the extension study. Unlike other current disease modifying therapies (DMTs) in which stopping treatment usually results in resumed disease activity, LEMTRADA continues to have a durable effect far beyond the two annual treatment courses. In fact, in more than 70 per cent of clinical trial patients, disability scores improved or remained stable over three years.¹


“The approval of LEMTRADA represents an important new treatment option for Canadians living with MS. In clinical trials, LEMTRADA demonstrated impressive effectiveness following two treatment courses for patients with active relapsing MS,” said Dr. Anthony Traboulsee, Associate Professor of Neurology and Medical Director of the UBC Hospital MS Clinic of Vancouver Coastal Health. “Our own experience in treating 35 patients through clinical trials with LEMTRADA has been extremely positive.”

LEMTRADA was approved by Health Canada in December 2013. The approval was based on data from the LEMTRADA clinical development program comparing treatment of LEMTRADA to high-dose subcutaneous interferon beta-1a (Rebif®) – which is dosed three times per week – in patients with RRMS who had active disease. In a controlled Phase 3 clinical study, LEMTRADA was more effective compared to Rebif at reducing both the annualized relapse rates (ARR) and the accumulation of disability was significantly slowed in patients given LEMTRADA vs. Rebif.²


In clinical trials, LEMTRADA demonstrated an ARR reduction of 49.4 per cent when compared with Rebif (p<0.0001), and the proportion of relapse-free patients was significantly (p<0.0001) higher in LEMTRADA patients than Rebif (65.4 per cent and 46.7 per cent, respectively). In addition, the risk of sustained accumulation of disability (SAD) over six months was reduced by 42 per cent in patients who received LEMTRADA versus Rebif (p=0.0084).²


“The approval and availability of LEMTRADA represents an important advancement for the MS community,” said Dr. Karen Lee, Vice-President, Research, Multiple Sclerosis Society of Canada. “The more treatment options that are available, the more choices Canadians living with MS have to potentially improve their overall quality of life.”

In November 2013, Genzyme’s AUBAGIO® (teriflunomide) 14 mg was approved by Health Canada as monotherapy for the treatment of patients with RRMS to reduce the frequency of clinical exacerbations and to delay the accumulation of physical disability. The approval was based on efficacy data from two Phase III clinical trials – TEMSO (TEriflunomide Multiple Sclerosis Oral) and TOWER (Teriflunomide Oral in people With relapsing remitting multiplE scleRosis). In the TEMSO trial, AUBAGIO 14 mg significantly reduced the annualized relapse rate (p=0.0005) and the time to disability progression (p=0.0279) at two years versus placebo in patients with RRMS. In the TOWER trial, AUBAGIO 14 mg significantly reduced the annualized relapse rate (p=0.0001) and the time to disability progression sustained for 12 weeks (p=0.0442) was statistically significantly reduced versus placebo in patients with RRMS.

“The Canadian approval and availability of LEMTRADA and AUBAGIO represent an important milestone for Genzyme and demonstrate our focus on scientific innovation and commitment to MS patients,” said Peter Brenders, General Manager, Genzyme Canada. “We are proud of our commitment to long-term leadership and partnership with the MS community.”

LEMTRADA is supported by a comprehensive and extensive clinical development program that involved 1,188 patients, resulting in 2,363 patient-years of safety follow-up.
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