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Another MS Drug Application Submitted for FDA Approval

6/13/2012

Applications for Lemtrada™ (alemtuzumab), a potential therapy for MS, have been submitted by Genzyme Corp. to both the U.S. Food and Drug Administration and to European regulators. The potential MS therapy for relapsing MS is already approved to treat leukemia under the name Campath®, and Genzyme executives called results from a second Phase III trial for Lemtrada, released earlier this year, “unprecedented.” 

Genzyme's clinical development program for Lemtrada included two Phase III studies in which results for Lemtrada were superior to Rebif(R) (high dose subcutaneous interferon beta-1a) on clinical and imaging endpoints, including a reduction in relapse rate. In addition, as presented at the 2012 American Academy of Neurology meeting, some patients with pre-existing disability treated with Lemtrada in the CARE-MS II trial were more than twice as likely to experience a sustained reduction in disability over two years than patients treated with Rebif.

Side effects of Lemtrada include potential autoimmune illnesses, including thyroid disorders and disorders in which the immune system attacks blood platelets, which can cause bleeding. The drug is given by daily infusion for five days, and then daily infusion for three days, 12 months later.



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