Friday, 25 August 2017

Another eagle? No - a Maven has landed !

It's official now, oral cladribine (Mavenclad) has just been given the nod by the EU Commission.

Whatever the somewhat clumsy detail of the license, and wherever the ensueing discussions with funders will lead on the ground, this is excellent news.

Big congratulations to Merck KgA for resurrecting their cladribine programme after BartsMS had started their own given the excellent data produced back in the 90s and 00s, and about which we have been reporting extensively, on this blog and elsewhere. 

Here's a reminder of the positive opinion by the EMA's CHMP, which now triggered the rubber stamping by the European Commission:



With Ocrevus licensed in the US, waiting to hear from the EMA, and now Mavenclad licensed in Europe, and expected discussions with the FDA, almighty campaigns are underway to treat you as pwMS with these compounds, and for market shares. 

BartsMS will try and do their bit to insure you remain top of the agenda, no matter what, and in spite of our own conflicts.


CoI:  Multiple, including payments for consultancy & lecturing by Roche and MerckKgA.

16 comments:

  1. Congrats
    How muc€ €s going to cost..€€€€€€€€€€€€€€€

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    Replies
    1. Ha! If I would know. Wait for tomorrow's post by MD, which includes a little balance sheet of what - yes - Merck KgA, but also - yes - BartsMS have achieved in the "cladribine arena"; you'll find there is potential for virtually every pwMS to get their hands on the drug, and yes you're allowed to think beyond the European & North American pill boxes.

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    2. What about ppms & soms? If MS is oessentially one disease?

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    3. We have a number of people taking the generic version.

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    4. Yes, we have treated pwMS outside the NHS England criteria, check reference #36 in our recent paper: http://journals.sagepub.com/doi/pdf/10.1177/1352458517726380

      #MS-Chariot is the word - we have the trial concept, however need extra funding. If you can, check the "Donate" button above. Thanks!

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  2. Damn. More lymphocyte depletion. I hope it's not as bad as Tecfidera for that, I'm in the less than 5000 range and next month may have to stop the dmf for a while.

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    1. Please see our paper in neurology N2. The depletion of CD8 is about 20percent and CD4 by about 40percent. But we think the B cell depletion is key.

      We have been dose adapting to limit lymphopenia hopefully it will not drop efficacy.

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    2. "But we think B cell depletion is key" then Ritux/ocrelizumab should be the optimal choice. Of course generic cladribine will or should be cheaper. But just as effective?

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    3. Check our recent batch of papers; the effect of cladribine is mainly, if not entirely, mediated by its B cell depleting effect; whether cladribine mainly suppresses memory B cells, which we think are crucial for effective MS immunotherapy, remains to be seen. Perhaps there will be some news at ECTRIMS/ACTRIMS later this year.

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  3. Thanks for reply
    Cladribine is a medication used to treat hairy cell leukemia (HCL, leukemic reticuloendotheliosis)

    So its the same drug use for cancer ? Certain there must be a generic
    Right?

    Danke

    Luis

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    1. Yes intravenous or subcutaneous variants are generic. You need about 60percent less because oral route gives forty percent bioavailability compared to 100percent for the generics.

      £165 pet 10mg dose in UK,about 100 dollars.

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    2. I took cladribine here in US. I tried to price shop, but there is no price transparency unless it is for a commodity drug like metformin or simvastatin. I finally found the vials for about $460 per from a specialty pharmacy. For the 2nd year, they said $1500 per. When I exclaimed "Holy S***, that's triple the price!, they gave me the previous years price. I think they're just making it up.

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    3. Thank Dr mouse thats cheap
      Obrigado

      Luis

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  4. I don't expect a reply but I'll comment anyway. I never considered any relationship between Dr. G and Merck. All I care about is the bottom line of another approved medication that works well for the MS community. After all, that is all that matters. Thank you. Cathy Chester

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  5. I pulled the following from the MS Trust website added on 25th Aug. So we might get mavenclad on the NHS by April/May 2018?

    https://www.mstrust.org.uk/news/news-about-ms/cladribine-mavenclad-gets-european-licence-highly-active-relapsing-ms

    25/08/17.

    " Cladribine will now need to be appraised by NICE and the SMC to determine NHS availability in the UK. NICE has started the process and the MS Trust is contributing to the appraisal.
    A decision from NICE is expected to be published in February 2018, with the drug potentially available on the NHS in England and Wales three months later ".

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