European Commission approves label expansion of Roche ’s Hemlibra to include people with moderate haemophilia A in the EU

Hemlibra, already approved for severe haemophilia A in the EU, will now also provide an effective and convenient prophylactic treatment option for people with moderate haemophilia AModerate haemophilia A can have a significant impact on the lives of people affected, with only 15% living a bleed-free life1The approval is based on the HAVEN 6 results, whereHemlibra demonstrated effective bleed control and a favourable safety profile in people with moderate haemophilia A without inhibitors2Basel, 01 February 2023 - Roche (SIX: RO, ROG; OTCQX: RHHBY) today announced that the European Commission approved the expansion of the Hemlibra ® (emicizumab) European Union (EU) marketing authorisation. The label will now include the routine prophylaxis of bleeding episodes in people with haemophilia A (congenital factor VIII deficiency) without factor VIII inhibitors, who have moderate disease (FVIII ≥1% and ≤ 5%) with a severe bleed ing phenotype.3 Haemophilia A affects around 900,000 people worldwide,4,5 approximately 14% of whom have a moderate form of the disease.6“We welcome the European Commission ' s decision to approve Hemlibra also for people with moderate haemophilia A in the EU, since even moderate disease can produce bleeds that cause irreversible joint damage and impact quality of life, ” said Levi Garraway, M.D., Ph.D., Roche’s Chief Medical Officer and Head of Global Product Development. “As its benefit expands to broader populations, we remain committed to deter...
Source: Roche Investor Update - Category: Pharmaceuticals Source Type: news