Overview
- On 26 February 2026, the EMA’s CHMP issued a positive opinion recommending EU marketing authorisation for Xolremdi for adults and adolescents aged 12 and older with WHIM syndrome under exceptional circumstances.
- Mavorixafor, the active substance in Xolremdi, antagonises CXCR4 to mobilise neutrophils, lymphocytes and monocytes from the bone marrow into peripheral blood.
- In a randomised, double‑blind, placebo‑controlled study of 31 patients, Xolremdi increased circulating mature neutrophils and lymphocytes, showed some reduction in infections, and showed no demonstrated effect on warts, with no preventive effect on malignancies derived.
- The medicine will be supplied as 100 mg hard capsules, with treatment initiation limited to physicians experienced in diagnosing or managing immune deficiencies.
- The product holds orphan designation and carries post‑authorisation obligations with annual reviews, and the SmPC will be published after a European Commission decision on the marketing authorisation.