News
CHMP gives negative opinion for emapalumab to treat primary haemophagocytic lymphohistiocytosis. -Swedish Orphan Biovitrum
Swedish Orphan Biovitrum AB (publ) (Sobi) announced that the Committee for Medicinal Products for Human use (CHMP) has adopted a negative opinion recommending a refusal of the marketing authorisation for emapalumab for the treatment of primary haemophagocytic lymphohistiocytosis (pHLH) in children under 18 years of age in Europe.
The negative opinion was given after the re-examination requested by Sobi after the initial opinion in July 2020.
Condition: Primary Hemophagocytic Lymphohistiocytosis
Type: drug
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