European CHMP negative opinion of emapalumab (Gamifant) for treatment of primary haemophagocytic lymphohistiocytosis in children under 18 years of age
Based on inadequate and inconclusive supporting data, the, it could not be determined if the benefits of emapalumab outweigh its risks in the treatment of primary haemophagocytic lymphohistiocytosis, hence marketing authorisation was refused.
Source:
European Medicines Agency