Results from Sanofi’s ALTUVIIIO XTEND-Kids phase 3 trial published in NEJM
Betsy Goodfellow | July 22, 2024 | News story | Research and Development | Altuviiio, Haematology, Sanofi, haemophilia
Sanofi has announced that full results from the XTEND-Kids phase 3 study were published in The New England Journal of Medicine (NEJM), demonstrating the efficacy, safety and pharmacokinetic profile of ALTUVIIIO (antihemophilic factor [recombinant], Fc-VWF-XTEN Fusion Protein).
According to the press release, the drug is a ‘first-in-class, high-sustained factor 8 replacement therapy, [which] is approved for adults and children with haemophilia A for routine prophylaxis and on-demand treatment to control bleeding episodes as well as for perioperative management (surgery)’.
The results published in NEJM demonstrate that the drug met its primary and secondary endpoints, including occurrence of factor 8 inhibitors and annualised bleed rates (ABRs).
Dietmar Berger MD PhD, global head of development and chief medical officer at Sanofi, commented: “The XTEND-Kids data validate the connection between high-sustained factor activity levels and improved health outcomes, including joint health. Offering a treatment option that emphasises effective bleed protection in children with haemophilia can help give families increased peace of mind when their loved ones participate in everyday activities. The results are a testament to our scientific expertise and commitment to redefine the standard of care for children living with haemophilia through ALTUVIIIO and our broader portfolio of haemophilia therapies.”
Betsy Goodfellow
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