EMA issues safety alert on alemtuzumab


  • Dawn O'Shea
  • Univadis Medical News
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The safety committee of the European Medicines Agency (EMA) is recommending permanent restrictions on the use of Lemtrada (alemtuzumab) in patients with relapsing-remitting multiple sclerosis.

The announcement follows the introduction of interim safety measures in April, while the EMA’s Pharmacovigilance Risk Assessment Committee (PRAC) reviewed reports of severe immune-mediated and cardiovascular adverse events linked to the treatment, with several deaths reported.

The PRAC has recommended restricting Lemtrada for use in adults with relapsing-remitting multiple sclerosis that is highly active despite adequate treatment with at least one disease-modifying therapy or if the disease is worsening rapidly with at least two disabling relapses in a year and brain imaging showing new damage. Lemtrada should no longer be used in patients with an increased risk for certain cardiovascular or bleeding disorders and those who have autoimmune disorders other than multiple sclerosis.

The PRAC has also recommended updating the physician’s guide with advice to minimise the risk of serious events occurring shortly after infusion, as well as autoimmune conditions that could occur months after the last Lemtrada treatment.

The PRAC recommendations will now be sent to the EMA’s Committee for Medicinal Products for Human Use (CHMP), which will adopt the Agency’s final opinion.