In the European Union (EU), alemtuzumab is indicated for adult patients with relapsing-remitting multiple sclerosis, with active disease defined by clinical or imaging features. It can be considered as an initial therapeutic for treatment-naïve patients with active disease and for patients relapsing on prior disease-modifying therapy.

Healthcare providers should adhere to the alemtuzumab EU label, which gives a broad definition of patient eligibility for treatment; alemtuzumab is not suitable for patients with inactive relapsing-remitting multiple sclerosis, those stable on current therapy, or patients with progressive multiple sclerosis.

The Risk Management Program in the EU and other countries in addition to the Risk Evaluation and Mitigation Strategy in the USA are critical to ensure early detection of potential adverse events arising during and after alemtuzumab treatment and to ensure compliance with monitoring requirements. Data from an ongoing extension study, from real-world studies, and from post-marketing safety data will also be important to establish long-term safety of alemtuzumab treatment.