![]() ![]() ![]() Quality of life data from the XTEND-1 study were recently presented at the 64 th American Society of Hematology (ASH) Annual Meeting & Exposition. We are hopeful that A ltuviiio (efanesoctocog alfa) will help deliver on this goal by offering unprecedented factor activity levels with once-weekly dosing, fulfill ing its potential as a best-in-class therapy for hemophilia A. Efanesoctocog alfa prophylaxis improved physical health (p5% of participants overall) were headache, arthralgia, fall, and back pain.ĭietmar Berger, MD, PhD Global Head of Development and Chief Medical Officer at Sanofi “ We are steadfast in our commitment to develop ing novel treatment option s that have a me aningful impact for patients.A statistically significant and clinically meaningful reduction in ABR (77%) versus prior factor VIII prophylaxis (p40 IU/dL for the majority of the week and at 15 IU/dL at Day 7.Treatment with efanesoctocog alfa prophylaxis resulted in significant and clinically meaningful improvements in physical health, pain, and joint health. The data from the pivotal XTEND-1 Phase 3 study published in NEJM show that efanesoctocog alfa met primary and key secondary endpoints, demonstrating clinically meaningful prevention of bleeds and superior bleed protection compared to prior factor VIII prophylaxis based on an intra-patient comparison. The data show that efanesoctocog alfa can offer patients increased bleed protection, leading to improved outcomes, such as reduced pain and improved physical functioning, that may impact daily life with a redu c ed treatment burden. Based on th e XTEND-1 study results assessing efanesoctocog alfa, we have the oppor tun ity to provide near normal factor activity levels for an extended period of time ( the majority of a week ) with a single dose, which is a first for hemophilia A. Currently, they often need to make trade - offs between bleed protection and dosing frequency. The severity of hemophilia is determined by the level of clotting factor activity in a person’s blood.Īngela Weyand, MD Investigator of the XTEND-1 Clinical Trial and Associate Professor at Michigan Medicine “ We are excited about the potential for efa nesoctoco g alfa to address unmet needs by allow ing people living with hemophilia to enjoy an active lifestyle. Hemophilia A is a rare, lifelong condition in which the ability of a person’s blood to clot properly is impaired, leading to excessive bleeds that can result in joint damage and chronic pain, and potentially impact their quality of life. Efanesoctocog alfa is currently under priority review by the United States Food and Drug Administration (FDA) and the target action date for the decision is February 28, 2023. These data demonstrate that efanesoctocog alfa delivered normal to near-normal factor activity levels (>40%) for the majority of the week with once-weekly dosing. P aris and Stockholm – January 25, 202 3 – Pivotal study data published in T he New England Journal of Medicine (NEJM) continues to highlight the efficacy, safety, and pharmacokinetic profile of efanesoctocog alfa, an investigational treatment for hemophilia A. NEJM publishes once-weekly efanesoctocog alfa Phase 3 data demonstrating its potential to transform the treatment landscape for people with hemophilia A ![]()
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