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Hemophilia is mostly a hereditary disease that prevents the body from clotting and forming a blood clot to stop bleeding
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This causes the patient to bleed longer after injury, is prone to bruising, and increases the chance of hemorrhagic joints or bleeding in the brain
Pharmaceutical companies Sanofi and Sobi today announced that a Phase III study of efanesoctocog alpha in previously treated patients with severe hemophilia A met its primary endpoint, as well as a key secondary goal
.
The companies noted that data from the XTEND-1 trial will form the basis for regulatory submissions starting this year
The non-randomized study included 159 patients over 12 years of age with severe hemophilia A who had previously received factor VIII replacement therapy
.
The prophylaxis arm of the trial included subjects receiving efanesoctocog alpha at a dose of 50 IU/kg weekly for 52 weeks
prevention
First-line results showed clinically meaningful prevention of bleeding events in patients receiving weekly prophylaxis over 52 weeks, with an average annual bleeding rate (ABR) of 0.
71
.
71
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First-line results showed clinically meaningful prevention of bleeding events in patients receiving weekly prophylaxis over 52 weeks, with an average annual bleeding rate (ABR) of 0.
"We believe that efanesoctocog alpha offers higher protection and longer duration," said Dietmar Berger, global head of development at Sanofi
.
Efanesoctocog alpha, also known as BIVV001, is an investigational recombinant factor VIII therapy designed to prolong bleeding protection in people with hemophilia A through once-weekly prophylactic dosing
.
Sobi decided to choose to develop the drug in 2019
Original source:
Original source:https://firstwordpharma.
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