NLT-gruppen rekommenderar landstingen att använda Lemtrada (alemtuzumab) för behandling av aktiv skovvis förlöpande MS. Lemtrada blev godkänt för användning inom EU i september 2013 och är det första utvalda läkemedel som ingår i ett pilotprojekt med en ny gemensam process för ordnat införande.
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.
Cambridge, Mass. – June 28, 2013 – Genzyme, a Sanofi company, 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.
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 - 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).
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