Sunday, 6 March 2016

In the Word of the Marathon man Is it Safe?

If you have seen Marathon Man (the film) you will know the scene of "Is it safe". So on the way to emergeny dentist this morning it sprang to mind.

Cladribine failed with the regulators based on safety issues
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                                                 MS Drug                     Cladribine
______________________________________________________
PML                                     Natalizumab :1:50-100  Not reported
                                             Fingolimod       Yes
                                             Tecfidera          Yes
                                             anti-CD20         Yes

Secondary Autoimmunities Alemtuzumab  50%        Not Reported
                                             HSCT              10%

Grade 3/4 Lymphopaenia    Alemtuzumab  >95%            25%

Malignancies in Trials         Ocrelizumab 8 verses 0      3 verses 0
 (verse placebo)                   Not different compared to other DMT
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Given their recent track records of approvals, would the regulators be accused of bias if they continue to reject access



CoI: None. ProfG PI on CLARITY study.

3 comments:

  1. Yes, MSers are Dustin Hoffman and Pharma/regulators are Laurence Olivier.......open up and say "more high priced drugs please":-(

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  2. Well, it has some "thing" strange this whole story of refusal of approval of Cladribine for MS ...

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  3. Hey there Mouse Doctor. If we added the following two rows to your graph above, how would each of the drugs you list fare?

    .........................................MS Drug Cladribine
    -----------------------------------------------------------------
    Permanently Suppresses Immune System:
    Can Harm Fertility (either sex):
    -----------------------------------------------------------------

    I'm not being snarky, I've just read that Cladribine can do both (100% likely on the first question, and somewhat likely on the second one), and I'm wondering how the other drugs stack up on both of those issues. I'll likely need to have a talk with my neuro about escalating my drug therapy when I see her next (Copaxone isn't doing it for me anymore), and I'm trying to weigh the pros and cons between Nat, Alem, and Clad. If Nat or Alem have less permanent immune suppression and reproductive issues than clad, I'll probably push her for one of the two. If they have similar problems, then I don't see any point in asking for them over clad.

    ReplyDelete

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