On November 14, 2014, the U.S. Food and Drug Administration (FDA) approved Lemtrada (alemtuzumab) for the treatment of patients with relapsing forms of multiple sclerosis (MS) who have responded inadequately to two or more MS drugs. Lemtrada is already approved in over 40 countries around the globe including the EU, Canada and Australia.
The FDA approval of Lemtrada is a significant milestone for people living with relapsing MS. Lemtrada demonstrated superior efficacy over Rebif on annualized relapse rates in two pivotal randomized Phase III open-label rater-blinded studies in patients with relapsing remitting MS which were the basis for approval. The clinical development program for Lemtrada involved nearly 1,500 patients including patients at the Swedish MS Center with more than 6,400 patient-years of safety follow-up.
Lemtrada has a unique dosing and administration schedule of two annual treatment courses. The first treatment course is administered by intravenous infusion on five consecutive days, and the second course is administered on three consecutive days, 12 months later. Lemtrada’s long-lasting effects may profoundly influence the course of relapsing MS, but will require careful and sustained monitoring for side effects.
The label in the U.S. for Lemtrada comes with a boxed warning stating that there is a risk of serious, sometimes fatal autoimmune conditions as well as serious and life-threatening infusion reactions. It may also cause an increased risk of malignancies including thyroid cancer, melanoma and lymphoproliferative disorders.
A comprehensive risk evaluation and mitigation strategy (REMS) will be instituted in order to help detect and manage the serious risks. This REMS program has been developed to ensure that access to Lemtrada is only through certified prescribers, healthcare facilities and specialty pharmacies and to also ensure that patients are enrolled in the REMS program. Lemtrada is expected to be available in December 2014.
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