Posted by Michael Wonder on 18 Dec 2022
CHMP recommends expansion of EU label for Hemlibra to include people with moderate haemophilia A
16 December 2022 - The positive CHMP opinion is based on the results of the HAVEN 6 trial, which demonstrated effective bleed control and a favourable safety profile of Hemlibra in people with moderate haemophilia A without inhibitors.
Roche today announced that the EMA's CHMP has recommended expansion of the Hemlibra (emicizumab) European Union marketing authorisation.
