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    Home > Medical News > Latest Medical News > AstraZeneca's new indications for major complement C5 inhibitors receive FDA priority review qualification

    AstraZeneca's new indications for major complement C5 inhibitors receive FDA priority review qualification

    • Last Update: 2021-12-24
    • Source: Internet
    • Author: User
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    Article source: Medical Rubik's Cube Info

    Author: Shi Bei

    On December 21, AstraZeneca announced that it had acquired a supplementary license application (sBLA) for the complement C5 inhibitor Ultomiris (ravulizumab-cwvz), a leading company on the complement track, for the treatment of adult systemic myasthenia gravis (gMG).
    It has been accepted by the FDA and has been granted priority review qualifications

    .

    gMG is a rare and debilitating chronic autoimmune neuromuscular disease that can cause loss of muscle function and severe weakness
    .
    It is estimated that there are 64,000 confirmed cases of gMG in the United States

    .

    Ultomiris is the first and only approved long-acting C5 complement inhibitor with immediate, complete and continuous complement inhibition
    .
    It works by inhibiting the C5 protein at the end of the complement cascade, which is part of the human immune system

    .
    When the C5 protein is activated in an uncontrolled manner, the complement cascade overreacts, causing the body to attack its own healthy cells

    .

    This marketing application is based on the results of a phase III clinical study of Ultomiris in the treatment of gMG patients
    .
    At the 26th week, the MG-ADL score of the patients treated with Ultomiris had a significant improvement compared with the baseline level and continued until the 52nd week (26-week randomized control period + 26-week open label expansion period)

    .
    In the test

    .
    The safety of Ultomiris is consistent with the safety observed in phase III trials for the treatment of paroxysmal nocturnal hemoglobinuria (PNH) and atypical hemolytic uremic syndrome (aHUS)

    .
    The European Union and the Japanese Health Bureau are currently reviewing Ultomiris' regulatory application for the treatment of gMG

    .

    Ultomiris and Soliris are the two most important listed products obtained by AZ in acquiring Alexion for US$39 billion
    .
    As Ultomiris is currently approved for the treatment of PNH and aHUS, sales in the first half of 2021 reached US$701 million, a year-on-year increase of 48%

    .

    On August 20th, AstraZeneca announced that the Phase III CHAMPION-ALS study of Ultomiris in the treatment of adult amyotrophic lateral sclerosis (ALS) was evaluated by the Independent Data Monitoring Committee (IDMC) and did not reach the clinical endpoint in the pre-specified interim analysis
    .
    Based on the committee's recommendation, Alexion decided to terminate the study early

    .
    This is also the first setback that AstraZeneca has encountered since its acquisition of Alexion on July 21 this year

    .

    In addition to ALS, Ultomiris is approved for the treatment of neuromyelitis optica spectrum disorder (NMOSD) indications with a very high probability of expansion.
    According to Alexion's latest research and development progress update in April, NMOSD trial data may be announced in the second half of 2022

    .

    Piper Sandler analyst Christopher Raymond stated in a report in February that in 2025, Alexion's global sales revenue on MG indications may reach US$3.
    06 billion, and revenue on NMOSD may reach US$1 billion

    .

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