New data reinforce the benefit of early preventative treatment with Roche ’s Hemlibra for babies with severe haemophilia A

Phase III HAVEN 7 primary data presented at ASH 2023 provide additional confidence in the favourable efficacy and safety profile of subcutaneous Hemlibra given soon after birth1At nearly two years median follow-up in the descriptive, single-arm study, no babies experienced spontaneous bleeds requiring treatment, and all treated bleeds were as a result of trauma1Safety results were consistent with previous studies of Hemlibra, with no new safety signals observed1The HAVEN 7 study was developed in collaboration with the haemophilia A community, to generate additional evidence for the prophylactic treatment of infants with haemophilia ABasel, 09 December 2023 - Roche (SIX: RO, ROG; OTCQX: RHHBY) announced today that the primary analysis of the Phase III HAVEN 7 study reinforced the efficacy and safety of Hemlibra ® (emicizumab) in previously untreated or minimally treated infants with severe haemophilia A without factor VIII inhibitors. Results showed that Hemlibra achieved meaningful bleed control in babies up to 12 months of age, and was well tolerated.1 The new data were presented at the 65th American Society of Hematology (ASH) Annual Meeting and Exposition taking place 9-12 December 2023, in San Diego, California, and included in the press programme.“Haemophilia A can have a devastating impact on any patient, but this is especially true for infants, where the emotional and physical stress due to frequent hospital visits, treatment administration and other worries can be ...
Source: Roche Media News - Category: Pharmaceuticals Source Type: news