LEMTRADA alemtuzumab

Drug Class

CD52-directed cytolytic monoclonal antibody

Mechanism

Alemtuzumab binds to CD52 on B and T lymphocytes, causing antibody-dependent cellular cytolysis and complement-mediated lysis, depleting circulating lymphocytes to reduce neuroinflammation.

Approved Indication

Treatment of patients with relapsing forms of multiple sclerosis (MS) who have had an inadequate response to two or more therapies.

What This Means For Patients

Lemtrada is a cell-depleting monoclonal antibody therapy for relapsing-remitting multiple sclerosis (MS). It is administered in two annual treatment courses to reduce disease relapse rates. Due to safety considerations, its use is generally reserved for patients who have not responded to other therapies. It is available under the special-import drug policy in the Hainan Boao Lecheng pilot zone.

Regulatory Approvals

• FDA — approved (2014) — label
• EMA — approved (2013) — source

Pivotal Clinical Evidence

• CARE-MS I — Cohen et al., Lancet 2012 (NCT00530348) — DOI

Sources

• https://www.accessdata.fda.gov/drugsatfda_docs/label/2014/103948s5139lbl.pdf
• https://www.ema.europa.eu/en/medicines/human/EPAR/lemtrada
• https://doi.org/10.1016/S0140-6736(12)61769-3