, a Sanofi company (EURONEXT: SAN and NYSE: SNY), announced today that the Committee for Medicinal Products for Human Use (CHMP) of the European Medicines Agency (EMA) has issued a positive opinion for approval of LEMTRADA™ (alemtuzumab) for the treatment of adult patients with relapsing remitting multiple sclerosis (RRMS) with active disease defined by clinical or imaging features.
In addition, the CHMP issued a positive opinion on new active substance designation (NAS) for AUBAGIO
(teriflunomide). Earlier this year, the CHMP issued a positive opinion recommending the approval of AUBAGIO for the treatment of adult patients with relapsing remitting MS.
The European Commission (EC) is expected to render a final decision to grant marketing authorizations for LEMTRADA and AUBAGIO in the EU in the coming months.
“Today’s CHMP opinions set the stage for the approval of two important new treatment options for MS patients. Treatments to-date have addressed some of the unmet needs in MS, but still have limitations,”
said David Meeker, MD, Genzyme President and CEO.
“Upon approval, physicians will have the ability to prescribe LEMTRADA for appropriate relapsing remitting patients based on their impressions of clinical or imaging characteristics regardless of duration of disease or treatment history. Expectations among the MS community are high for LEMTRADA and with today’s positive CHMP opinion we are a step closer to making this very innovative treatment available for MS patients in Europe.”
The positive CHMP opinion for approval of LEMTRADA was based on data from the CARE-MS I and CARE-MS II trials, in which LEMTRADA was significantly more effective than Rebif
(subcutaneous interferon beta-1a 44 mcg three times weekly) at reducing relapse rates. In CARE-MS II, accumulation of disability was significantly slowed in patients given LEMTRADA vs. Rebif, and importantly, patients treated with LEMTRADA were significantly more likely to experience improvement in pre-existing disability.
“Today’s announcement from Genzyme represents a key milestone in the extensive program evaluating LEMTRADA in multiple sclerosis,”
said Professor Alastair Compston, Head of the Department of Clinical Neurosciences at the University of Cambridge, United Kingdom.
“The superior efficacy of Lemtrada vs. Rebif in the clinical trials, which was sustained despite infrequent administration, represents an approach to treatment that promises to reshape the future for many people with active relapsing-remitting multiple sclerosis.”
LEMTRADA has a novel 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.