The European Commission has approved label expansion of Roche's (RHHBY) Hemlibra to include people with moderate haemophilia A in the European Union.
Hemlibra, already approved for severe haemophilia A in the European Union, will now also provide an effective and convenient prophylactic treatment option for people with moderate haemophilia A, Roche said in a statement.
The approval is based on the results of the phase III HAVEN 6 trial, in which Hemlibra demonstrated effective bleed control and a favourable safety profile in people with non-severe haemophilia A without factor VIII inhibitors, where prophylaxis was clinically indicated. The decision was also based on real world data.
" The label expansion will provide an effective and convenient prophylactic treatment option with a favourable safety profile for people in the EU with moderate haemophilia A with a severe bleeding phenotype," the company said.
Hemlibra is approved as a prophylactic treatment option for people with haemophilia A with factor VIII inhibitors in more than 110 countries and for people without factor VIII inhibitors in more than 100 countries worldwide.
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