New Data Reinforce the Benefit of Early Preventative Treatment With Genentech’s Hemlibra (emicizumab-kxwh) for Babies With Severe Hemophilia A
SOUTH SAN FRANCISCO, Calif. — Genentech, a member of the Roche Group, has announced that the Phase III HAVEN 7 study has provided further evidence regarding the effectiveness and safety of Hemlibra (emicizumab-kxwh) in infants with severe hemophilia A. The study focused on previously untreated or minimally treated babies with hemophilia A who did not have factor VIII inhibitors. The results of the study, which were presented at the American Society of Hematology’s Annual Meeting and Exposition, demonstrated that Hemlibra successfully controlled bleeding in infants up to 12 months old and was well-tolerated.
Hemophilia A can have a profound impact on infants, causing emotional and physical stress for both the babies and their parents and caregivers. The study’s findings reinforce the importance of initiating prophylactic treatment as early as possible after birth, particularly through subcutaneous administration methods. This is particularly valuable for young babies as it can be difficult to find accessible veins for treatment.
Severe hemophilia A poses a significant burden on infants and their caretakers. While the standard of care for hemophilia treatment is regular prophylaxis starting at a young age, many infants do not begin prophylaxis until after their first year of life due to the challenges associated with treatment. Hemlibra offers a flexible treatment solution that can be administered subcutaneously from birth, with different dosing frequencies.
According to Dr. Steven Pipe, a professor of pediatrics and pathology at the University of Michigan, These results reinforce the benefit of starting prophylaxis as soon as possible after birth, as well as for the use of subcutaneous treatments, which are especially valuable in young babies where access to veins can be very difficult.
Genentech’s chief medical officer and head of Global Product Development, Dr. Levi Garraway, expressed his confidence in the results of the HAVEN 7 study. He stated, The results of HAVEN 7 provide additional confidence in the efficacy and safety profile of Hemlibra for babies with severe hemophilia A and add to its extensive clinical and real-world evidence across all ages. He also highlighted the importance of collaborating with the hemophilia A community to better understand and address the needs of individuals affected by this condition.
The World Federation of Hemophilia treatment guidelines emphasize the significance of prophylaxis and its ability to improve long-term outcomes while reducing the risk of severe complications like intracranial hemorrhage. By expanding the evidence base for early preventative treatment with Hemlibra, this study contributes to advancing treatment standards for babies with severe hemophilia A.
The results of the HAVEN 7 study support the use of Hemlibra for infants with severe hemophilia A and reinforce the importance of early intervention. By providing a treatment option that can be administered from birth and minimizing the treatment burden, Hemlibra offers hope for infants and their families in managing this challenging condition.
As research and development in the field of hemophilia treatment progress, Genentech remains dedicated to listening and responding to the needs of those affected by hemophilia A, with the goal of continuously improving treatment options and quality of life for patients of all ages.
Please note that the HAVEN 7 study results were presented at the American Society of Hematology’s Annual Meeting and Exposition without any explicit reference to the news agency or editor’s names.
