Lemtrada Initiated in Select MS Patients for First Time in U.S.

Genzyme announced that select patients in the United States are the first to have initiated treatment for relapsing forms of multiple sclerosis (MS) with Lemtrada (alemtuzumab) injection through the restricted distribution program.

Alemtuzumab is a monoclonal antibody that selectively targets CD52, a protein abundant on T and B cells. Treatment with alemtuzumab results in the depletion of circulating T and B cells thought to be responsible for the damaging inflammatory process in multiple sclerosis.

Lemtrada is only available via the restricted distribution program. The Lemtrada REMS (Risk Evaluation and Mitigation Strategy) is based on a risk management program to allow for early detection and management of some of the serious risks associated with Lemtrada. Prescribers, healthcare facilities, and pharmacies must be certified to have access to Lemtrada to ensure that patients receiving the drug are enrolled in the REMS program. The label includes a boxed warning noting a risk of serious, sometimes fatal autoimmune conditions, serious and life-threatening infusion reactions and also noting Lemtrada may cause an increased risk of malignancies including thyroid cancer, melanoma, and lymphoproliferative disorders.

Lemtrada is available as single-use vials that deliver 12mg/1.2mL (10mg/mL).

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