Lemtrada Gets Positive Opinion From European CHMP in MS

Susan Jeffrey

Disclosures

June 28, 2013

The European Medicines Agency's (EMA's) Committee for Medicinal Products for Human Use (CHMP) has adopted a positive opinion supporting marketing authorization for alemtuzumab (Lemtrada, Genzyme Corporation/sanofi-aventis) for the treatment of relapsing-remitting multiple sclerosis.

Specifically, the approval indication is "treatment of adult patients with relapsing remitting multiple sclerosis (RRMS) with active disease defined by clinical or imaging features," a release from EMA notes. "The CHMP, on the basis of quality, safety and efficacy data submitted, considers there to be a favourable benefit-to-risk balance for Lemtrada and therefore recommends the granting of the marketing authorisation," the statement adds.

Part of the authorization is a pharmacovigilance plan. "Treatment with Lemtrada should be initiated and supervised by a neurologist experienced in the treatment of patients with MS," the EMA release says. "Specialists and equipment required for the timely diagnosis and management of the most frequent adverse reactions, especially autoimmune conditions and infections, should be available," as well as resources for the management of hypersensitivity and/or anaphylactic reactions.

The drug is currently under review by the US Food and Drug Administration (FDA). The application for approval is based on results of 2 phase 3 trials, CARE-MS I in treatment naïve patients with relapsing-remitting MS, and CARE-MS II in MS patients with disease activity despite treatment. Both studies compared alemtuzumab with interferon beta-1a (Rebif, EMD Serono, Inc.), and both showed reduction in relapse rates for those taking the new agent.

Alemtuzumab is a humanized monoclonal antibody directed against the cell surface glycoprotein CD52. "The mechanism by which alemtuzumab exerts its therapeutic effects in multiple sclerosis is not fully elucidated," the EMA notes. "However, research suggests immunomodulatory effects through depletion and repopulation of lymphocytes."

The drug is also given in 2 intravenous treatments, 1 year apart. In the CARE MS trials, it was administered at a dose of 12 mg/day once a day for 5 days at baseline, then once a day for 3 days at 12 months.

"The benefits with Lemtrada are its ability to reduce the relapse rate and slow disability progression," the statement says. "The most common side effects are infusion associated reactions (including headache, flushing, nausea, urticaria, rash, pruritus, pyrexia and fatigue), upper respiratory tract infection, urinary tract infection, lymphopenia and leukopenia. In addition, side effects pertaining to the thyroid gland (including over-active or under-active thyroid gland, or goitre and auto-immune conditions) were commonly observed in patients treated with alemtuzumab."

Patients treated with alemtuzumab must be given the Patient Alert Card and Patient Guide and be informed about the risks of treatment, it adds.

"Detailed recommendations for the use of this product will be described in the summary of product characteristics (SmPC), which will be published in the European public assessment report (EPAR) and made available in all official European Union languages after the marketing authorization has been granted by the European Commission," the statement concludes.

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