Norgine Gains EU Approval for XOLREMDI® to Treat WHIM Syndrome

Norgine has announced the European Commission's marketing authorisation for XOLREMDI® (mavorixafor), marking a first for treating WHIM syndrome in the EU. This approval follows positive feedback from the EMA's Committee for Medicinal Products for Human Use (CHMP). It represents a crucial development for those with this rare immunodeficiency, granted under exceptional circumstances due to the syndrome's rarity.

XOLREMDI® is targeted at individuals aged 12 and above, aiming to boost mature neutrophils and lymphocytes. The syndrome stems from CXCR4 receptor dysfunction, causing elevated infection risk. A Phase 3 trial underpinned the approval, involving 31 participants.

Norgine and X4 Pharmaceuticals' agreement will see Norgine commercialising XOLREMDI® across Europe, Australia, and New Zealand, while X4 oversees production and supply. This collaboration seeks to expedite availability to those eligible.