Friday, 28 June 2013

Good news: alemtuzumab gets a first-line license in Europe

Today is a historic day for people with MS living in Europe. #MSBlog #MSResearch

"Somebody asked for some good news. It doesn't come much better than this."

Press release:  Genzyme, a Sanofi company, announced today that the Committee for Medicinal Products for Human Use (CHMP) of the European Medicines Agency (EMA) has issued a positive opinion for approval of Aalemtuzumab for the treatment of adult patients with relapsing remitting multiple sclerosis (RRMS) with active disease defined by clinical or imaging features.

"What does this mean? It means that we will have the option of using Alemtuzumab in MSers with relapsing disease who are active. This means it can be used as a first line agent and it won't only be limited to MSers with highly active MS. This means the EMA have shifted their position and realised that MSers and neurologists need the option of choosing an early highly-effective therapy early in the disease. The question now is will NICE and other payers adopt this strategy."

"We were in the process of setting up a pan-European petition and protest to lobby against Alemtuzumab getting a second or third-line license. This means we can hold back on the protest for the time being; however, we may need this campaign to lobby Genzyme to price the drug at a price European countries can afford and to encourage local or regional payers to allow wide access to the drug."

"This means flat-lining may become a reality for those MSers willing to take the risk of early effective treatment."

"This ruling will also set off a chain of events in the industry. If alemtuzumab can get a relatively broad license why not natalizumab and fingolimod? Yes, why not? I suspect we will see the EMA push back on these drugs as well and maybe European neurologists can join our colleagues in the USA who will surely have the luxury of using all highly-effective treatments early in relapsing MS"

"Several of my colleagues in the US have stopped using first-line injectables; I can't argue with them. Why waste time on an ineffective drug when you can receive a highly-effective drug with a good chance of flat-lining or improving your condition?"

"This is also a time to reflect on the alemtuzumab programme and thank all the MSers for taking the risks of being in the trials, the trial team at Barts and The London, for their hard work and dedication, Genzyme for investing in such a high-risk programme, Professor Compston for being a such brave pioneer and to Dr Coles for devoting his academic life to Alemtuzumab. I have particular respect for Dr Coles' role in the programme; his commitment and dedication to Alemtuzumab has been truly outstanding."


"Are you prepared to wait 15-20 years for the results of early highly-effective treatment strategy to read out? Will alemtuzumab treatment early in the course of MS prevent secondary progressive MS? Will alemtuzumab treatment early in the course of MS cure MS? It won't in all of you, but it may in some."

CoI: multiple

Other relevant posts of interest:

25 Jun 2013
Flatlining MS disease activity; what do we need to do to make it a reality? #MSBlog #MSResearch "In the last few weeks we have been discussing the paradigm of early effective treatment as an emerging treatment strategy to ...

20 Jun 2013
Survey results on MS as a dementing illness. #MSBlog #MSResearch "Next to my posts on CCSVI the 'Rebranding MS a Dementia' post caused quite a stir in the blogosphere. It is clear from the comments in relation to this ...
12 Jun 2013
"For me the best thing about going to conferences is that it allows you thinking time, and time to interact with like minded colleagues. After my platform presentation on early aggressive treatment several European neurologists ...
17 Jun 2013
Rebranding MS a dementia (3): Cognitive impairment in asymptomatic MS (or RIS). Cognitive impairment may begin before the first attack of MS. #MSBlog #MSResearch "This is an old post that needs more air time. It shows ...
14 Jun 2013
Rebranding MS as a Dementia: part 2. "What do you think of this of short animation? It tries to explain the impact of MS on the brain; in the other words the early phases of MS Dementia." ...


29 comments:

  1. This is a sad day. This drug is barely what we need in MS. It is lethal and hugely dangerous. It only works, if at all, in a select cohort of subjects.

    We need to focus on remyelination therapies. I hope the NHS discards Alemtuzumab and doesn't cave in to greedy pharmaceutical lobbying. Big Pharma needs to stop trying to kill us MSers.

    ReplyDelete
    Replies
    1. A Dr Dre disciple I assume.

      You clearly have not been reading this blog or the papers that show beyond reasonable doubt that alemtuzumab is a highly effective treatment. Remyelination strategies will only work if you get rid of the autoimmunity. If you don't the immune system will simply attack the new myelin.

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    2. MS is not an autoimmune disease. Neurodegeneration is a primary factor and autoimmunity is secondary. This is going the arse-end way of getting to the front, which seems a recipe for disaster.

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    3. Well that's your opinion but seeing as giving alemtuzumab early stops MS in its tracks the hypothesis that MS is primarily due to neurodegeneration doesn't seem to fit.

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    4. Wow some fantastic news and the doom and gloom brigade come out.

      Yes there will be a bumpy road ahead.........but an important step for European MSers being first line is a game changer.

      We need a focus on remyelination yes....but better not to demyelinate in the first place. More surving axons is more to remyelinate

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  2. At first I was so happy to read this post, but then it dawned on me that I will not benefit from Alemtuzumab. The NHS will drag its feet and I'll miss the boat. I suppose most of us will fall into the camp in which it won't cure us because we have now missed the boat. We do need repair and nerve-protection properties, but you scientists have failed us repeatedly. This is a horrible position to be in.

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    Replies
    1. We do need repair and nerve-protection properties, but you scientists have failed us repeatedly.

      "I feel like Charles Atlas with the responsibility of every scientist on our shoulders....It is the Neurologists who botch up the good scientists ideas :-)".

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  3. The NHS is so pathetic that they will probably licence Alemtuzumab as a second-line therapy before giving it to us all. They will argue that it can only be given to highly-active MSers and they will keep that stance for years until it gets cheaper, which it won't for years and years. Ever bit of good news is always tinged with harsh reality. This is such a losing battle.

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    Replies
    1. Fantastic news. Let's now hope NICE play ball too.

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  4. This is great news for lots of people. Well done to all concerned. Genzyme must bring the drug to the market quickly and affordably, and NICE must make it available to prescribers and patients as a matter of absolute priority.

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  5. Well done to the A's from Cambridge for their persistence

    and

    Well done to Prof G for his little unsung part in the story

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  6. Wonderful news; I will first in the queue for the drug! I sincerely hope they will allow switchers from Tysabri to receive the drug.

    Prof G I suggest you don't call off the petition but get the 100,000 signatures to force NICE to make the right choice for MSers. And another 100,000 signatures to make sure Genzyme make the drug affordable.

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  7. I was considering this therapy when i was first diagnosed but that there have been quite a few PML cases associated with Alemtuzumab to date so early in its development. so decided against it. do you think it will be necessary to check for JCV antibodies before considering this new therapy?
    Also heard it can cause one to become severely anaemic and need blood transfusions.
    Seems to be still many unknowns especially in relation to its safety long term..

    ReplyDelete
    Replies
    1. It's so true. Everyone is acting like Alemtuzumab is a panacea, but it will most likely only work in immediate MS cases, if that.

      This drug has a seriously high risk profile. I'd never touch it. I bet it costs a fortune, too.

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    2. Whilst your immune system gets suppressed for a long time the drug is out of the system quite soon this reduces risk of infection complications and problems of JC Virus

      The blood complications are limited by careful monitoring this occurs once a month for 5 years

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    3. The PML cases you mention were in those being treated for leaukaemia with alemtuzumab in much higher doses. As far as I know there have been no cases of PML in those people treated for MS with alemtuzumab.

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    4. All the cases of PML are in the cancer field none in MS. I think the risk of PML post-alemtuzumab is low. When the immune system reboots the immune response to viruses is intact

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  8. Great news. This is fantastic news for those diagnosed with RRMS in the future. I was on one of the trials and have been relapse free for nearly 7 years, no MRI activity and stable EDSS. It gives future MSers a choice. The side effects can be monitored and managed. It may not be for everyone, but to have it as an option is fantastic. Many thanks to the people in Cambridge and those on team G who have been involved. In the future e will look back on his as a big big advance in combatting this disease. For those who will not benefit, neuroprotective agents will hopefully be the next big breakthrough.

    As the late Margaret Thatcher said "rejoice, rejoice".

    ReplyDelete
  9. :D
    YAY! Really good news! Alemtuzumab would be my choice after Mitoxantrone runs out due to its lifetime maximum dose.

    Any news concerning the Thyroid Gland autoimmune thingy which could happen while on Alemtuzumab?

    ReplyDelete
    Replies
    1. The tyroid gland thingy risk is about 20% occurrence but this is treatable

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    2. Thanks.

      Does treatable mean I have to take another drug until I die or that I have to use a drug for a certain time??

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    3. My Dad had Graves disease. Treatment back then was surgical removal of a large part of the thyroid but I believe they now ablate the thyroid these days with radioactive Iodine (not as scary as it sounds!).
      http://en.wikipedia.org/wiki/Graves%27_disease

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  10. I'm surprised that Dr. Dre(adful)has not reared his head yet. He must be busy rapping at Glastonbury tonight.

    Alemtuzumab sounds too good to be true. The side-effects are a very worrying aspect of the drug and I worry that along with big costs may leave it hanging in limbo for a few years yet whilst our NHS decides whether to sanction it or not. The road will be a long one but at least we're on it now.

    I welcome neuro-protective treatments that promote remyelination, though the goal posts always seem to shift farther and farther away every year.

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    Replies
    1. Then we should get cladribine back on the agenda no evidence of autoimmunity like alemtuzumab and generic drug costs of less than £1000 even without NHS discount.

      Shift goal posts...no sure about this we just need a working trial design

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  11. This is great news. Thanks so much for all you do. I appreciate your hard work and concern for us MSers!

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  12. GREAT news!

    And that's true even though it will not help everybody personally or help right away.

    At least it's a step towards getting everybody onto effective treatment as early as possible

    (The people who don't agree are crazy)

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    1. Totally agree. And those who don't agree don't have to take it. It's about choice and giving the choice to patients who want the best available treatment ( if they are content to accept the risks - which are manageable).

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