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    X4 Pharmaceuticals Announces EMA Validation of Marketing Authorization Application (MAA) for Mavorixafor - licenced to Norgine for commercialisation in Europe.

    London (ots/PRNewswire) - Following the licensing agreement with X4
    Pharmaceuticals, Norgine is pleased to see the announcement from X4 today that
    their Marketing Authorization Application (MAA) for mavorixafor for the
    treatment of WHIM syndrome (warts, hypogammaglobulinemia, infections and
    myelokathexis), a rare primary immunodeficiency, has been validated for review
    and is now under evaluation with the European Medicines Agency's (EMA) Committee
    for Medicinal Products for Human Use (CHMP). In April 2024, mavorixafor received
    U.S. Food and Drug Administration approval as XOLREMDI®, an oral, once-daily
    treatment for use in patients 12 years of age and older with WHIM syndrome.

    Norgine is working with X4 to enable access to mavorixafor for patients in
    Europe, Australia and New Zealand and this regulatory milestone is an important
    step toward this goal.

    About X4 Pharmaceuticals

    X4 is delivering progress for patients by developing and commercializing
    innovative therapies for those with rare diseases of the immune system and
    significant unmet needs. Leveraging expertise in CXCR4 and immune system
    biology, X4 has successfully developed mavorixafor, an orally available CXCR4
    antagonist that is currently being marketed in the U.S. as XOLREMDI® in its
    first indication. The company is also evaluating additional uses of mavorixafor
    and is conducting a global, pivotal Phase 3 clinical trial ( 4WARD
    (https://neutropeniastudy.com/) ) in people with certain chronic neutropenic
    disorders. X4 is headquartered in Boston, Massachusetts and operates a research
    center of excellence in Vienna, Austria.

    About Norgine

    Norgine is a uniquely positioned, specialty pharmaceutical and consumer
    healthcare company, with more than EUR500 million of annual revenues and a
    120-year track record of bringing life-changing products to patients and
    consumers across their core markets of Western Europe, Australia, and New
    Zealand. Today's Norgine is a nimble, innovative, and high-performing company
    that has been transformed by a relentless focus on operational excellence to do
    the right thing by patients, push boundaries, and take strides into new
    therapeutic areas. The company's integrated approach - strong commercial
    capabilities, deep medical, regulatory and clinical expertise, in-house
    manufacturing, robust supply networks, and best-in-class enabling functions -
    ensures delivery of high-quality, transformative medicines quickly and
    effectively to more than 25 million patients annually.

    Logo - https://mma.prnewswire.com/media/597589/4648918/Norgine_Logo.jpg

    View original content: https://www.prnewswire.co.uk/news-releases/x4-pharmaceuti
    cals-announces-ema-validation-of-marketing-authorization-application-maa-for-mav
    orixafor---licenced-to-norgine-for-commercialisation-in-europe-302359812.html

    Contact:

    Neha Bhimbat,
    contact@norgine.com

    Additional content: http://presseportal.de/pm/80824/5956679
    OTS: Norgine




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    X4 Pharmaceuticals Announces EMA Validation of Marketing Authorization Application (MAA) for Mavorixafor - licenced to Norgine for commercialisation in Europe. Following the licensing agreement with X4 Pharmaceuticals, Norgine is pleased to see the announcement from X4 today that their Marketing Authorization Application (MAA) for mavorixafor for the treatment of WHIM syndrome (warts, …