Chronic Migraine -Atogepant on list for approval with the EMA.

imhotep

Well-known member
  • Mar 29, 2017
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    On a different thread I mentioned about the "Gepants" a class of drugs that targets Migraine - as a reply to a member's query re migraine drugs.
    FYI a transcript is copied below from a post made on 12 Sept 2021. Just more than a year ago.

    <snip>

    "It's considered as a systemic illness and not just a headache. It's really a brain disorder. There are different subtypes of migraine. For some a simple remedy like cooling the forehead (icepack) while keeping your feet in a warm bath works. Although a long term cure is not available, there are promising new drugs.
    Research has shown that the brain patterns do change 24 hrs ahead of migraine onset. There are a new family of drugs - Calcitonin gene-related peptide (CGRP) which works, but there are side effects including liver damage.
    But later, Monoclonal antobodies (CGRP mAbs) were developed, not cheap but considered safe. Some of these are still awaiting for FDA approval. CGRP mAbs are the latest preventative drugs for migraine. Hopefully may be one day there will be a cure.

    CGRP mAbs are not cheap.. Only used in chronic cases. But these are now available in the developed countries.
    There are several of them - erenumab (Aimovig), fremanezumab (Ajovy), galcanezumab (Emgality) & eptinezumab (Vyepti)
    Aimovig, Ajovy and Emgality are taken by an injection with a needle or automatic pen- (like the Diabetes pen)

    Some of these could be available in India. I believe they approved these recently.

    Also in the late stage of development are a family of drugs in tablet form. One of them a nasal spray (zavegepant). But only available in the US still."
    </snip>

    Back to the current topic...

    AbbVie recently applied approval for another drug in this class. - Atogepant (Qulipta in the US) from the EMA. This was granted FDA approval in 2021 as soon as the Phase III trial report was released. Atogepant is an orally administered CGRP receptor antagonist (gepant) specifically developed for the prophylaxis (preventative) treatment of migraine.
    Phase III, and the subsequent PROGRESS and ADVANCE trials have all shown promising results.
    The study met its primary endpoint of a statistically significant reduction in mean monthly migraine days across the 12-week treatment period compared to placebo. This was found across all active treatment arms of atogepant – 10 mg, 30 mg, and 60 mg QD doses.

    Chronic migraine sufferers would benefit from this line of treatment. Reported side effects are nausea, constipation, and fatigue..
    Also warnings to seek medical advice for those who -
    • Have kidney problems or are on dialysis
    • Have liver problems
    • Are pregnant or plan to become pregnant. It is not known if QULIPTA will harm your unborn baby.
    • Are breastfeeding or plan to breastfeed. It is not known if QULIPTA passes into your breast milk.
    (Qulipta as marketed in the US is expensive, a month's supply of 30 tablets is said to be around $950.00.)