X4 Pharmaceuticals announced that the European Medicines Agency's Committee for Medicinal Products for Human Use (CHMP) has issued a positive opinion recommending approval of mavorixafor, marketed as XOLREMDI, for the treatment of WHIM syndrome across the European Union. The endorsement represents a significant milestone for the biopharmaceutical company and addresses a critical treatment gap in Europe, where no approved therapies currently exist for this ultra-rare immunodeficiency disorder. Mavorixafor has already received FDA approval in the United States.
The positive CHMP opinion advances the drug toward final European Commission authorization, which is anticipated to occur during the second quarter of 2026. Upon approval, mavorixafor would establish itself as the sole available treatment option for WHIM syndrome in the EU market.
X4 Pharmaceuticals has established a commercialization partnership with Norgine to bring the therapy to European, Australian, and New Zealand markets. The agreement includes potential milestone payments of up to €226 million alongside royalty payments projected in the mid-twenties percentage range, contingent upon achievement of specified commercial targets and regulatory approvals.