LONDON, January 25, 2025 /PRNewswire/ — Following the licensing agreement with X4 Pharmaceuticals, Norgine is pleased to see today’s announcement by X4 regarding its Marketing Authorization Application (MAA) for mavorixafor for the treatment WHIM syndrome (warts, hypogammaglobulinemia, infections and myelokathexis), a rare primary immunodeficiency, has been validated for review and is currently under evaluation by the Committee for Medicinal Products for Human Use (CHMP) of the European Medicines Agency (EMA). In April 2024mavorixafor received approval from the U.S. Food and Drug Administration as XOLREMDI®, a once-daily oral treatment for patients 12 years and older with WHIM syndrome.
Norgine is working with X4 to provide access to mavorixafor for patients in Europe, Australia And New Zealand and this regulatory milestone is an important step toward that goal.
About X4 Pharmaceuticals
X4 advances patients by developing and commercializing innovative therapies for people with rare immune system diseases and significant unmet needs. Leveraging its expertise in CXCR4 and immune system biology, X4 successfully developed mavorixafor, an orally available CXCR4 antagonist, currently marketed in the United States as XOLREMDI® in its first indication . The company is also evaluating other uses of mavorixafor and is conducting a pivotal global Phase 3 clinical trial (4th ROOM) in people with certain chronic neutropenic disorders. X4 has its headquarters 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 over €500 million in annual revenue and a 120-year track record of delivering life-changing products to patients and consumers in their main markets Western Europe, AustraliaAnd New Zealand. Norgine today is an agile, innovative and high-performance company that has been transformed by a relentless focus on operational excellence to do the right thing for patients, push boundaries and advance 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 the rapid and efficient delivery of transformative medicines high quality to more than 25 million patients per year.
SOURCE Norgine
