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Bioverativ and Sobi Release Long-Term Study Results for Extended Half-Life Therapies

December 14, 2018
Sobi Releases Long-Term Study Results for Extended Half-Life Therapies

Swedish Orphan Biovitrum AB (Sobi) and Bioverativ Inc. announced the results of ASPIRE and B-YOND, the most comprehensive long-term studies of extended half-life factor therapies in hemophilia. The data was presented at the 60th Annual Meeting and Exposition of the American Society of Hematology (ASH), which was held December 1-4, 2018 in San Diego, CA.

The data from both studies confirmed the safety and sustained efficacy of Eloctate ® and Alprolix ® over four years of treatment in previously treated adult, adolescent, and pediatric patients with severe hemophilia A and B. The results demonstrated that long-term prophylactic treatment consistently improved annualized bleed rates, including joint bleeds, across all patient populations studied and at extended dosing intervals.

"These data add to a significant body of evidence showing that efmoroctocog alfa [Eloctate] and eftrenonacog alfa [Alprolix] provide protection from all types of hemophilia-related bleeds with individualized and flexible dosing regimens across all study populations," said Tim Harris, PhD, DSc, executive vice rresident, research and development at Bioverativ. "We remain focused on and committed to providing complete protection for people with hemophilia."

Debilitating joint disease, which is caused by repeated bleeds into joints over time, is one of the most common complications for people with hemophilia. An interim, post-hoc analysis of ASPIRE published in Haemophilia, the official journal of the World Federation of Hemophilia (WFH), found that a prophylactic regimen of Alprolix can lead to continuous improvement in joint health, regardless of prior treatment regimen, severity of joint damage, or target joints. However, additional studies will be needed to confirm and validate these findings.

"Joint protection remains a significant challenge in the long-term treatment of hemophilia keeping individuals from living a life without constraints of their disease and these results confirm that our therapies can play a role in the effective prevention of joint bleeds," said Milan Zdravkovic, Head of Research & Development and Chief Medical Officer at Sobi. "In addition to providing the clinical evidence to support the long-term use of our therapies, we continue to explore the impact of Fc fusion on joint health."

Source: Sobi press release dated December 1, 2018