Alemtuzumab’s Article 20

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Use of multiple sclerosis medicine Lemtrada restricted while EMA review is ongoing

EMA 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, 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.

In addition to the restriction, EMA’s safety committee (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).

Healthcare professionals should consider stopping treatment in patients who develop signs of these conditions and patients should immediately seek medical help if they experience 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.

For more information on a the EMA’s ‘Article 20 pharmacovigilance procedures’.

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9 comments

  • So, if you are a patient that was considering starting Lemtrada (and don’t meet the restricted criteria) where does this leave you? How long do these reviews take? What’s a good ‘holding strategy’ while you wait for the outcome?

  • Very bad news 😦
    We patients might need to start a petition to keep the drug available, since it is the most effective DMT, the closest to a cure before HSCT. It saves many more lives than harms.
    EMA needs to understand the importance of preventing progressive MS. But I am afraid they wont. They will probably choose the conservative road.

    • Yep, it was me.

      As I have said before I have been accused of abusing the Barts-MS blog and using it as a platform to promote myself. I will continue to post on this blog but will be limiting my posts to factual content and no random personal musings and off-beat topics.

      I have also stopped using the moniker Prof G, some don’t like it either. I will now post under Barts-MS. All my personal postings will now be done on Medium. Let’s hope these measures will be satisfactory for everyone.

      We don’t have a full-time blog administrator and tend to do things on the fly. I assume MD and I were penning these posts simultaneously hence the overlap. This is not the only time, nor will it be the last time, that there will be two posts on the same topic 😉

      • “Let’s hope this move will now satisfy everyone.”

        You know that the opposite is the case so I assume you have a different reason for this change. Certainly not about pleasing or not any critics. Please at least create a patient’s forum within the site to talk about research news and drug interactions, so that it has a reason of existance. It is not the first time you abandon the blog and probably not the last. We, on the other side are always here.

  • Just to clarify: has there been anything else that has come out about the safety of Alemtuzumab? As far as has been reported, there are 13 cases of intracranial bleeds, strokes or dissection (in totality). Can you give a sense of how many patients have been treated worldwide with Lemtrada? I think the number that I have read is 40,000 patients treated. So that means a 1/3000 chance (approx) of vascular adverse event. Is my math correct?

  • Gavin hi,

    I know it has been only a couple of months since your post on HSCT (the one commented 77 times). Do you see any value in posting more on this topic in light on the alemtuzumab restriction?
    I hate saying this, but preferably on Medium. It is your personal views we are after.

    Tony

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