EMA hints that natalizumab would not get a 1st-line license in JCV negative MSers

The European Medicines Agency (EMA) had some concerns and was of the provisional opinion that Natalizumab could not be approved for treating patients with relapsing-remitting multiple sclerosis that is not highly active and who do not have antibodies against the JC virus.

Source: EMA (Q&A below)

“In my opinion this is a great pity. Natalizumab is probably the most effective DMT we have in appears to have a favourable risk profile in the JCV seronegative group. This means MSers have to fail 1st-line DMTs, by having highly-active MS, before accessing Natalizumab. Therefore there is no filling in of the hole in the doughnut yet; not with fingolimod nor natalizumab. When are the regulators going to move on this? MS is a brain shredder; the sooner MSers get access to highly-effective therapies the better.”

CoI: multiple 

About the author

Prof G

Professor of Neurology, Barts & The London. MS & Preventive Neurology thinker, blogger, runner, vegetable gardener, husband, father, cook and wine & food lover.


  • Just who exactly are the people making these decisions at the EMA? it is obvious they do not have the best interests of MSers at heart.
    It seems to me that far too many interpret the Hippocratic oath of "do no harm" as "do nothing".
    This has to change.

  • So we have to be really disabled before we can have the most effective treatments?

    bureaucracy, I shit it!

  • Brain shredding disease. That should be the name instead of MS. Too many people think MS isn"t that bad. They only look on the surface. My neuro in the states echoed what you said Dr.G that natalizumab is hands down the most effective DMT.

    • Shredding is not my adjective; it comes from the West Wing.


      "The West Wing: The War at Home (#2.14)" (2001)

      President Josiah "Jed" Bartlet: You really gotta ask yourself, what's the point in being a superpower anymore.

      President Josiah Bartlet: What are you, my Zen master? Can I be in charge of my own mind?

      President Josiah Bartlet: We didn't get a chance to talk again last night.
      Abbey Bartlet: I don't think we should.
      President Josiah Bartlet: Talk?
      Abbey Bartlet: No.
      President Josiah Bartlet: Ever?
      Abbey Bartlet: Oh, if wishing made it so, Jed.

      Abbey Bartlet: We had a deal!
      President Josiah "Jed" Bartlet: Yes, we had a deal.
      Abbey Bartlet: Yes, Jed. Look at me! Do you get that you have M.S.?
      President Josiah "Jed" Bartlet: Abbey…
      Abbey Bartlet: Do you get that your own immune system is shredding your brain? And I can't tell you why. Do you have any idea how good a doctor I am and that I can't tell you why?
      President Josiah "Jed" Bartlet: I've had one episode in two years.
      Abbey Bartlet: Yes, but relapsing-remitting M.S. can turn into secondary-progressive M.S. oftentimes ten years after the initial diagnosis which is exactly where we'll be in two years! Do you know what that's going to look like if it happens?

      President Josiah "Jed" Bartlet: They won't let me smoke inside, but you can pee in Leo's closet?

      President Josiah "Jed" Bartlet: We weren't prepared for someone to try and outfox us with a stratagem so sophisticated, it's an entire generation beyond "Hey, look! Your shoelaces are untied!"? Is that how I just lost nine guys to a damn street gang with a ham radio? They lured us there so that they could kill nine American soldiers!

  • Since the company has withdrawn the applications the EMA does not have to make any decision at all

  • If alemtuzumab is approved, is it the EMA that makes the decision that it should be second line or first line? No doubt if it is it'll be the former. With the headline figures its risk benefit profile seems much more acceptable than that of natalizumab.

    Is it time for someone to start a proper "hard and early" campaign? I'd suggest a govt e petition, but having just checked the MS related ones, there aren't many signatures sadly. I think there may be enough evidence to mobilise – none of us have 20 years to wait and see.

  • I've had a small taste of what MS can do and I can tell you that there are many risks that I would be prepared to take in order to decrease disability from this disease. The current first line therapies simply don't cut it.

  • Having taken and benefited from Tysabri for over 4 yrs I have now found out that I am JCV positive.I wish to come off the drug and move to Fingolimod because the risk for PML is too much for myself and my family.
    It is not straight forward that you can make this transition. I believe it is irresponsible for patients to be provided with Tysabri when there is no safety net when you stop taking it.Careful consideration needs to be given for what happens next – you can read some of the cases of MS re-bound once Tysabri is stopped to see this.
    With no plan for supporting patients with alternatives it is the patients who face marked increases in disability. There is now a whole cohort of Tysabri patients who are abandoned to deal with this.

  • Everyone has a different risk tolerance, but for me the chance of PML is not one I would take. Bad enough to have one 'brain shredding' disease. I won't risk two.

    I do take fingolimod. The risk of heart attack or infection does not horrify me the way PML does.

By Prof G



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