Xolremdi (mavorixafor)

OrphanExceptional circumstancesAdditional monitoring

Region: 🇪🇺 EU
Active substance: mavorixafor
Company: Norgine B.V.
Status: Authorised
Therapeutic area: Primary Immunodeficiency Diseases
CHMP opinion: Thu 26 Feb 2026
EU approval: Mon 27 Apr 2026
Designations: Orphan, Exceptional circumstances, Additional monitoring
Application: EMEA/H/C/006496
ATC: L03AX24
Official record: www.ema.europa.eu

Indication

Xolremdi is indicated in patients 12 years of age and older for the treatment of WHIM syndrome (warts, hypogammaglobulinemia, infections and myelokathexis) to increase the number of circulating mature neutrophils and lymphocytes.

Regulatory milestones

Mon 27 Apr 2026🇪🇺 EU approval (EC decision)

Xolremdi (mavorixafor) approved in the EU

Marketing authorisation to Norgine B.V.; Orphan, Exceptional circumstances, Additional monitoring · source

Thu 26 Feb 2026🇪🇺 CHMP positive opinion

Xolremdi (mavorixafor): CHMP positive opinion

Norgine B.V.; Orphan, Exceptional circumstances, Additional monitoring · source

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Information from official EMA, FDA, Federal Register and SEC records. Dates marked company-announced come from the company's own SEC filing; dates marked estimate are calculated, not official. Not investment or medical advice; always confirm on the source.