European drug regulator recommends restricted use of Lemtrada

1 November 2019

Lemtrada (alemtuzumab) should be restricted to people with highly active relapsing remitting MS according to a review carried out by the European Medicines Agency's (EMA) drug safety committee.

Highly active relapsing remitting MS covers people who continue to have relapses despite taking at least one disease modifying drug (DMD) or if MS is worsening rapidly with at least two disabling relapses in a year and MRI scans show new MS activity. In addition, Lemtrada must no longer be used in people with certain heart, circulation or bleeding disorders or in people who have auto-immune disorders other than MS.

The recommendations also include new measures to identify and treat problems that may occur after having a Lemtrada infusion.

Earlier this year, the EMA began their review of Lemtrada following reports of side effects affecting the heart, blood vessels, liver and immune system. These side effects are rare but potentially serious. While the review was being carried out, Lemtrada use was restricted to people with relapsing remitting MS that continued to be very active despite taking at least two disease modifying drugs.

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