EMA Begins Safety Review of MS Drug Lemtrada

Regulatory NewsRegulatory News | 12 April 2019 |  By 

The European Medicines Agency (EMA) on Friday initiated a review of Sanofi’s multiple sclerosis (MS) drug Lemtrada (alemtuzumab) following new reports of immune-mediated conditions and problems with the heart and blood vessels of those taking the medicine, including deaths.

“As a temporary measure while the review is ongoing, 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,” EMA said.

EMA’s Pharmacovigilance Risk Assessment Committee (PRAC) is carrying out the review and will make a set of recommendations.

In the meantime, PRAC has recommended an update of the product information for Lemtrada to inform patients and healthcare professionals about cases of:
  • “immune-mediated conditions, including autoimmune hepatitis (with damage to the liver) and haemophagocytic lymphohistiocytosis (overactivation of the immune system which may affect different parts of the body);
  • problems with the heart and blood vessels occurring within 1–3 days of receiving the medicine, including bleeding in the lungs, heart attack, stroke, cervicocephalic arterial dissection (tears in the lining of the arteries in the head and neck);
  • severe neutropenia (low levels of neutrophils, a type of white blood cell that fights infections).”
Back in November 2018, the US Food and Drug Administration also warned that serious cases of stroke and tears in the lining of arteries in the head and neck have occurred in patients with MS shortly after they received Lemtrada.



© 2023 Regulatory Affairs Professionals Society.

Tags: Lemtrada, PRAC, Sanofi

Discover more of what matters to you

No taxonomy