Use of Lemtrada restricted while EMA review is ongoing

16 April 2019

The European Medicines Agency has started a review of the multiple sclerosis medicine Lemtrada (alemtuzumab) following new reports of immune-mediated conditions (caused by the body’s defence system not working properly) and problems with the heart and blood vessels with the medicine, including fatal cases.

As a temporary measure while the review is ongoing, French pharma major Sanofi’s (Euronext: SAN) Lemtrada should only be started in adults with relapsing-remitting multiple sclerosis that is highly active despite treatment with at least two disease-modifying therapies (a type of multiple sclerosis medicine) or where other disease-modifying therapies cannot be used. Patients being treated with Lemtrada who are benefitting from it may continue treatment in consultation with their doctor.

Lemtrada has been an important drug for Sanofi but, due to increased competition, sales in 2018 were down 11% to 402 million euros ($455 million).

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