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.
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
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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