24.01.2025, 2808 Zeichen
London (OTE) - 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 ) 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 Ꞓ500 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_L...
View original content: https://www.prnewswire.co.uk/news-
releases/x4-pharmaceuticals-announces-ema-validation-of-marketing-
authorization-application-maa-for-mavorixafor---licenced-to-norgine-
for-commercialisation-in-europe-302359812.html
Digital press kit: http://www.ots.at/pressemappe/PR80824/aom
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