EMA Reviewing Safety Data for Lemtrada After Reports of Serious Treatment Side Effects

The European Medicines Agency (EMA) is reviewing safety data for Sanofi Genzyme‘s Lemtrada (alemtuzumab) following new reports of serious treatment side effects.

Lemtrada is a humanized monoclonal antibody used to slow disease progression in adult patients with relapsing-remitting multiple sclerosis (RRMS). It works by blocking the activity of CD52, a protein found on the surface of immune cells, inactivating them and reducing neuroinflammation associated with multiple sclerosis (MS).

Lemtrada is normally recommended for patients with active MS (those who are experiencing relapses), and is administered by intravenous infusion (drip). So far, the therapy has been approved in more than 30 countries, including the European Union in 2013, and the U.S. in 2014.

The review of Lemtrada was issued by the European Commission and will be carried out by the Pharmacovigilance Risk Assessment Committee (PRAC), the EMA’s drug safety committee, which will submit recommendations.

As a preventative measure, during the review process access to Lemtrada by new patients will be restricted to those who continue to experience flare-ups despite having received treatment with at least two prior disease-modifying therapies, or who are ineligible to be treated with other disease-modifying agents.

Patients who already have begun treatment with Lemtrada will be allowed to continue if they are benefiting from it, provided they are closely monitored by their physicians.

In addition, the PRAC issued temporary recommendations to update the product information to inform patients and physicians about the occurrence of:

• Complications arising from immune system dysregulation, such as autoimmune hepatitis (liver damage caused by immune system overactivation) and hemophagocytic lymphohistiocytosis (a disorder that may affect several organs in the body and is caused by a systemic overactivation of the body’s immune system);
• Heart and blood vessel problems, such as heart attack, stroke, lungs’ bleeding, and cervicocephalic arterial dissection (tears in the arteries from the head and neck);
• Severe neutropenia (low white blood cell count).

The final recommendations will be sent to the Committee for Medicinal Products for Human Use (CHMP), which will issue an opinion. Based on that opinion, the European Commission will make the final decision that will apply to all members of the European Union.

In the meantime, the EMA is urging all healthcare providers to interrupt treatment in patients who show any signs of these conditions, and is alerting patients to seek immediate medical attention should they experience any unusual symptoms.

“EMA will now evaluate all available data on the safety concerns with the medicine, and consider any additional measures necessary to protect patients and whether there should be changes in the authorised use,” EMA stated in a press release.

A complete list of the recommendations for patients and healthcare professionals can be found here.