Saturday, 8 February 2014

Alemtuzumab gets a license in Mexico

Will MSers resident in the US travel south to Mexico to be treated with alemtuzumab? #MSBlog #MSResearch 

"Genzyme  announced that Mexico’s national regulatory authority, COFEPRIS, has approved alemtuzumab for the treatment of MSers with relapsing remitting forms of MS to slow or reverse the accumulation of physical disability and reduce the frequency of clinical exacerbations. This is remarkable for two reasons; firstly, they are acknowledging that alemtuzumab can reverse the accumulation of disability in MSers and secondly, that they have licensed the drug despite the FDA's decision not to. The fact that the Mexican licencse is more liberal that the Canadian license will give MSers in the US, who can afford it, an option of heading south for their treatment."


"With regard to the improvement in disability after alemtuzumab treatment is the observation that it can be delayed with over 1 in 10 MSers having an improvement after year 2 is remarkable. In my experience this is not unique to alemtuzumab and I have seen it on natalizumab. I therefore suspect it is due to being on highly-effective treatment that suppresses ongoing damage and allows endogenous or self repair to occur. I used to tell all the MSers I looked after that most recovery from relapses occurs within 6 months with some additional recovery up until year 2. This was obviously incorrect, with high efficacy DMTs MSers can expect improvement beyond that."

"I did an MS clinic yesterday and for some reason it was full of follow-ups of MSers on natalizumab. If it wasn't for discussions around being JCV positive, PML risk mitigation and switching because of the latter, these MSers would have been in and out of my consulting room in minutes; not because I don't want to see them simply because most of them are doing so well and have not symptomatic problems. A similar thing happens when I see the MSers who have been treated with alemtuzumab as part of the phase 3 clinical studies. It is simply amazing to see MSers who have had such active disease doing so well; we have really entered a new era of MS treatment. It is very satisfying."


CoI: multiple

8 comments:

  1. Thanks Prof G. I too share your view that we are entering a new era for RRMS. With B cell depleting treatments on the horizon, the future is very positive. I hope that some of the progressive trials also deliver some effective treatments. I can see that your job as a neuro must be much more satisfying knowing that you are really having a positive impact on patients' lives. Thanks for all your efforts.

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  2. Prof G do you force your patients who are high risk of PML to stop Tysabri?

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    1. Re: "Prof G do you force your patients who are high risk of PML to stop Tysabri?"

      I recommend you read the following post when I discuss this issue:

      http://multiple-sclerosis-research.blogspot.co.uk/2014/01/clinic-speak-end-organ-damage.html

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  3. Who said drug development in MS was cheap?

    Sanofi said it took a 612-million-euro charge in the quarter to account for the US Food and Drug Administration's December ruling that multiple sclerosis treatment Lemtrada is not ready for approval for the American market.

    http://www.skynews.com.au/businessnews/article.aspx?id=948185

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    1. Re: "Who said drug development in MS was cheap?"

      None of us have ever made this claim. This is is one of the reasons why there is no other model at present for drug development. Pharma, and Big Pharma, is really the only show in town when it come to phase 3 drug development in MS.

      Euro612M does not take into account the fact that this drug has been licensed in other markets. It shows you how large and influential the US market is when it comes to DMTs.

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  4. Prof G I'm confused by everything that's happening with Alemtuzumab. People talk about it like it's the big "breakthrough" for MS treatment but is that only because of the amazing results in the original phase II study? Were the CARE-MS studies not a bit disappointing compared with say Tysabri or Gilenya? For example the slide you show above show that the MSers taking Alemtuzumab in CARE-MSII were four times more likely to have improvement in disability. BUT...was that not a trial of people who have had a relapse on interferon randomized to continue the interferon or change to something stronger? Don't we already know that people that relapse on interferon are going to do better if we change their treatment? Do people that don't have relapses or have NEDA on interferon also improve whereas people on interferon who continue to relapse get worse?

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    1. The data about alemtuzumab does worry me a bit - did one of the studies not show a new or enlarging T2 lesion load in 49% of treated patients (I can't immediately find this on searching)? The relative risk reductions sound good for alemtuzumab, but much less so in absolute terms. And all this when compared against interferon which has been questioned in its efficacy.

      Don't get me wrong, I would take alemtuzumab if available, I just have niggles that it's not quite as good as hoped. I would also be concerned as to what other treatments you could safely take after having plumped for it if it seems to have failed. Is there a chance it's less effective than Tysabri?

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    2. I found this free article online written by Prof Coles himself that gives a summary of all the trials http://www.ncbi.nlm.nih.gov/pmc/articles/PMC3593763/

      I don't think the CARE-MSII study really tells us anything because unfortunately half of the MSers with relapses on interferon were forced to continue on their treament (in a time when Tysabri was available) rather than be switched to something stronger.

      The CARE-MSI trial is also a bit concerning. No difference in volume of T2 lesions, a decrease in new or enlarging T2 lesions (48% vs 58%) that only just reached significance AND at the end of two years no difference between the two groups in terms of disability. Remeber people in this trial had duration of MS less than 5 years and EDSS less than 3 so very early in the disease - the time when treatment is meant to have the biggest impact.

      The satefy profile to me is also worrying. I could live with thyroid problems but I'm not sure I would take the risk of thombocytopenia/bleeding or kidney failure. At least with Tysabri we know the risks and they are getting cleaer all the time with JCV titres now coming on board.

      If I were JCV positive and had failed interferon then I'd consider Alemtuzumab but I doubt there will be a flood of Americans rushing across the border for it. I know the FDA are not experts in MS but they are experts in trials of new drugs. Our doctors need to be guided by science or risk going back in time 50 years and relying on anecdotes like "A similar thing happens when I see the MSers who have been treated with alemtuzumab as part of the phase 3 clinical studies" above. At least from my reading the study results don't reflect these anecdotes

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