Nov 6, 2017

Interim study results recently published online in the journal Haemophilia, showed that prophylactic use of ELOCTATE® led to joint health improvements in a group of hemophilia A patients. Manufactured by Bioverativ Inc., ELOCTATE®, is a recombinant factor VIII Fc fusion protein (rFVIIIFc) therapy designed to keep the infused clotting factor circulating in the body longer, stretching the time between infusions.

The US Food and Drug Administration first approved ELOCTATE® in June 2014 for the control and prevention of bleeding episodes, surgical management and routine prophylaxis in adults and children with hemophilia A (factor VIII deficiency).

These interim data, which were announced by Bioverativ Inc. and Swedish Orphan Biovitrum AB in an October 31, 2017 press release, were drawn from patients enrolled in the ASPIRE study. This is an extension of the earlier A-LONG trial which was designed to measure the safety, efficacy and pharmacokinetics of ELOCTATE®. Results showed that individuals who had been receiving prophylactic infusions of the therapy for nearly three years saw regular improvements in their joint health regardless of prior treatment regimen, severity of joint damage or target joints.

Investigators acknowledged that improvements in joint health were even apparent in hemophilia A patients suffering from significant joint deterioration. “This is the first study to show that functional joint health can continue to improve using prophylactic treatment with an extended half-life factor therapy, even for those who have severe joint disease at the start of treatment,” said professor Johannes Oldenburg, MD, Institute of Experimental Haematology and Transfusion Medicine at the University of Bonn, Germany, and a lead author of the study.

Participants experienced positive outcomes related to target joints, with the most marked improvements related to joint swelling, range of motion and strength.

“These findings demonstrate the potential long-term benefit of prophylactic treatment with ELOCTATE® on joint health for people with hemophilia A, particularly for those with severe joint damage, regardless of their pre-study prophylaxis or episodic treatment regimens,” said Maha Radhakrishnan, MD, Senior Vice President of Medical at Bioverativ.

Source: Biovarativ press release dated October 31, 2017

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