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FDA rejects Gilead's would-be blockbuster filgotinib over toxicity concerns

Discussion in 'Other health news and research' started by Jaybee00, Aug 19, 2020.

  1. Jaybee00

    Jaybee00 Senior Member (Voting Rights)

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    https://www.fiercebiotech.com/biote...blockbuster-filgotinib-over-toxicity-concerns

    Testicular toxicity!

    Wow—This is the drug KDM was promoting, and planning to do trials with.


    See here

    https://www.s4me.info/threads/smci-...-profiles-in-me-cfs-subgroups”-lombardi.6114/


    What happened with this?

    Is Filg available in Benelux?
     
    Last edited: Aug 19, 2020
  2. Jaybee00

    Jaybee00 Senior Member (Voting Rights)

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  3. Kitty

    Kitty Senior Member (Voting Rights)

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    It wouldn't be the first anti-rheumatic to affect sperm counts, and if they return to normal when the drug is withdrawn, it may turn out to be an acceptable side effect – a reversible low sperm count isn't harmful to a man who's already fathered his children, or to one who isn't yet planning any. Also, rheumatoid arthritis affects around three times more women than men, so if it's the only serious concern, it would be irrelevant to the majority of patients. It may yet get approval eventually...
     
  4. MarcNotMark

    MarcNotMark Senior Member (Voting Rights)

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    I saw this safety overview (comparison with JAK inhibitors {Edit:and Humira} already on the market) posted in another place (so I cannot guarantee it's 100% correct) so rejection was not expected.
    As for lower sperm count, this was observed in preclinical trials with very high doses on rats, not so far in human trials.

    000.jpg
     
    Last edited: Aug 20, 2020
    Helen, Jaybee00 and Kitty like this.
  5. Jaybee00

    Jaybee00 Senior Member (Voting Rights)

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  6. MarcNotMark

    MarcNotMark Senior Member (Voting Rights)

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    Approval today in both Japan and Europe for Jyseleca / Filgotinib.
     
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