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

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.

10 comments

    • MV says:

      Do you think it has something to do with the Lamtrada? What other DMT’s have you used in the past? Are you out of work because you have been hospitalized and its been physically disabling? I hope you get better soon!

  1. Zuhaib says:

    I have had lemtrada quite recently and so far i havent had a relapse. I think it would depend on your body because each ones is different

  2. Debbie McGuire says:

    I had my first round of Lemtrada in fall of 2018. Not only has it been effective for me, and I experienced minimal issues post-treatment, but I am slowly seeing previously-existing neuropathy in my right foot fade. I also have experienced a slight, but noticeable, uptick in my energy levels. I’m a happy camper.

  3. Rita says:

    Please make sure anyone with MS diagnosis to look at their diet, vitamin D levels consumption of oily fish and moderate exercise. As most neurologist would not discuss these issues.

  4. Pam Lowing says:

    I had been using Rebif for a couple of years but still experiencing at least 2 significant relapses each year. I was invited to participate in a double-blind, pre-FDA approved drug study group in the US back in 2004ish. I was lucky since I knew I had the real drug — I got a rash which is one of the first side effects at the time. Since my treatment with alemtuzumab I haven’t been on any other MS drugs and had very few symptoms of relapse with only 2 steroid treatments in the past 14 years. Alemtuzumab did mess with my thyroid the first few years…sometimes it worked, sometimes not, but it’s been steady and controlled about the past 7 years. Yes, this treatment apparently can have serious complications, but it has improved my life dramatically.

  5. Jan Willem says:

    Neurologist of my daughter initially prescribed Ocrevus for her agressive RRMS because it had less side effects compared to Lemtrada. Only side effect was severe skin rash leaving little scars, big deal for a young woman already suffering from MS. Because she had a major relapse 5 months after starting Ocrevus she decided to have aHSCT. Since leaving hospital last december she is improving week over week, so we are extremely happy and hopeful she can live a normal life.
    Next step is to get aHSCT approved as standard care in The Netherlands. The major MS competence center first wants to test aHSCT against Lemtrada. Maybe this EMA review will change their minds and get them to offer aHSCT based on available smaller trials, experience in other EU countries and opinion of hematologists of EBMT and ASBMT declaring it “standard of care, clinical evidence available”.

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