CHMP recommends expansion of EU label for Hemlibra to include people with moderate haemophilia A

Thepositive CHMP opinion is based on the results of the HAVEN 6 study, which demonstrated effective bleed control and afavourable safety profile ofHemlibra in people with moderatehaemophilia A without inhibitors1Given that many people with moderatehaemophilia A may not receive prophylaxis, they may endure a worsened clinical burden with only 15% living a bleed-free life2If approved,Hemlibra, already approved for severehaemophilia A in the EU, will offer an effective and convenient prophylactic treatment option with afavourable safety profile for people with moderatehaemophilia ABasel, 16 December 2022 - Roche (SIX: RO, ROG; OTCQZ: RHHBY) today announced that the European Medicines Agency ’s (EMA) Committee for Medicinal Products for Human Use (CHMP) has recommended expansion of the Hemlibra® (emicizumab) European Union (EU) marketing authorisation. If approved, Hemlibra would also be indicated for the routine prophylaxis of bleeding episodes in people with haemophilia A (congenit al factor VIII deficiency) without factor VIII inhibitors, who have moderate disease (FVIII ≥1% and ≤ 5%) with a severe bleeding phenotype. It is estimated that people with moderate haemophilia A make up 14% of the haemophilia A population.3“We know that people with moderate haemophilia A can still have 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. “We’re ...
Source: Roche Investor Update - Category: Pharmaceuticals Source Type: news