Genzyme Receives Positive CHMP Opinion for Lemtrada


Genzyme for ™ (alemtuzumab) in Europe– CHMP also Recommends NAS Designation for AUBAGIO® (teriflunomide) Following Opinion on Approval in March 2013 –– Opinions Set Stage for Introduction of Two New Genzyme Therapies for Multiple Sclerosis in Europe –Paris, France – June 28, 2013 – Sanofi (EURONEXT: SAN and NYSE: SNY) and its subsidiary Genzyme announced today that the Committee for Medicinal Products for Human Use (CHMP) of theEuropean Medicines Agency (EMA) has issued a opinion for approval of LEMTRADA™(alemtuzumab) for the treatment of adult patients with relapsing remitting multiple sclerosis (RRMS) withactive disease defined by clinical or imaging features.

In addition, the CHMP issued a positive opinion on new active substance designation (NAS) forAUBAGIO® (teriflunomide). Earlier this year, the CHMP issued a positive opinion recommending theapproval 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 authorizationsfor 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 MSpatients. 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 toprescribe LEMTRADA for appropriate relapsing remitting patients based on their impressions of clinical orimaging characteristics regardless of duration of disease or treatment history. Expectations among theMS community are high for LEMTRADA and with today’s positive CHMP opinion we are a step closer tomaking 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 andCARE-MS II trials,…Read more

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