Posted by Michael Wonder on 16 Nov 2020
The CHMP has adopted a negative opinion for emapalumab in Europe for the treatment of primary HLH
13 November 2020 - Sobi today announced that the CHMP has adopted a negative opinion recommending a refusal of the marketing authorisation for emapalumab for the treatment of primary haemophagocytic lymphohistiocytosis 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.
