The EMA has launched a review into Genzyme’s multiple sclerosis drug Lemtrada (alemtuzumab) after reports emerged of treatment-related safety issues arising from heart, blood vessel and immune-mediated conditions, some of which were fatal.

The EMA has launched a review into Genzyme’s multiple sclerosis drug Lemtrada (alemtuzumab) after reports emerged of treatment-related safety issues arising from heart, blood vessel and immune-mediated conditions, some of which were fatal.

While the agency assesses the situation, it announced temporary advice that the drug "should only be started in adults with relapsing-remitting multiple sclerosis that is highly active despite treatment with at least two disease-modifying therapies 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."

PRAC, the EMA’s safety committee, has called for an update of Lemtrada’s product information to warn patients and professionals of a range of health issues, including severe neutropenia, autoimmune hepatitis and haemophagocytic lymphohistiocytosis, and heart and blood vessel issues occurring within three days of receiving treatment, including bleeding in the lungs, heart attack, stroke, and cervicocephalic arterial dissection.

Any patients who begin to develop signs of these conditions should stop treatment immediately under the direction of their healthcare professional, it is advised. Evaluation of the drug’s safety and efficacy is ongoing, with the EMA poised to take further action to protect patients, including altering the drug’s authorised uses, if necessary.

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