Cambridge, Massachusetts – 17 september 2013 – Genzyme, ett bolag i Sanofikoncernen (EURONEXT: SAN och NYSE: SNY) meddelade idag att den Europeiska kommissionen har gett marknadsföringstillstånd för Lemtrada™. Detta kommer kort tid efter godkännandet för Aubagio® som tillkännagavs den 30:e augusti. Företaget har som målsättning att snart börja lansera båda produkterna inom EU.
Genzyme, a Sanofi company (EURONEXT: SAN and NYSE: SNY), announced today the publication of results from the LEMTRADA™ (alemtuzumab) CARE-MS I and CARE-MS II pivotal studies in patients with relapsing-remitting multiple sclerosis (MS) in the November 1, 2012, online issue of The Lancet.
Genzyme, a Sanofi company (EURONEXT: SAN and NYSE: SNY), announced today new data from Genzyme’s clinical development programs for AUBAGIO® (teriflunomide) and LEMTRADA TM (alemtuzumab) will be presented at the 28th Congress of the European Committee for Treatment and Research in Multiple Sclerosis (ECTRIMS) in Lyon, France, October 10-13.
Paris, France – September 12, 2012 - Sanofi (EURONEXT: SAN and NYSE: SNY) and its subsidiary Genzyme announced today that the U.S. Food and Drug Administration (FDA) has approved AUBAGIO® (teriflunomide) as a new once-daily, oral treatment indicated for patients with relapsing forms of multiple sclerosis (MS).
Paris, France - August 27, 2012 - Sanofi (EURONEXT: SAN and NYSE: SNY) and its subsidiary Genzyme announced that Genzyme has received a Refuse to File letter from the U.S. Food and Drug Administration (FDA) in response to the supplemental Biologics License Application (sBLA) for the approval of LEMTRADA™ (alemtuzumab) as a treatment for relapsing multiple sclerosis.
Sanofi (EURONEXT: SAN and NYSE: SNY) and its subsidiary Genzyme today announced that the company has submitted a supplemental Biologics License Application (sBLA) to the U.S. Food and Drug Administration (FDA) and a marketing authorization application (MAA) to the European Medicines Agency (EMA) seeking approval of LEMTRADA™ (alemtuzumab) for treatment of relapsing multiple sclerosis (RMS).
Sanofi (EURONEXT: SAN and NYSE: SNY) and its subsidiary Genzyme announced today top-line results from the TOWER (Teriflunomide Oral in people With relapsing remitting multiplE scleRosis) trial that assessed the efficacy and safety of once-daily, oral teriflunomide in patients with relapsing forms of multiple sclerosis (MS).