SWEDISH ORPHAN BIOVITRUM AB The FDA decision date for efanesoctocog alfa, an investigational factor VIII therapy, is set for
Priority review is based on pivotal data from the XTEND-1 phase 3 study
Efanesoctocog alfa delivers high sustained factor activity levels in the normal to near-normal range for the majority of the week with once weekly prophylaxis dosing, providing higher protection for longer
The
"Factor therapy remains a cornerstone of haemophilia treatment, but innovation has been needed in this area to address challenges related to bleed protection and cumbersome treatment regimens," said
The BLA is supported by data from the pivotal XTEND-1 phase 3 study. Results were recently presented at the 30th
"We believe transforming the treatment paradigm for haemophilia A can only be achieved through elevating standards of care towards normal haemostasis," said
The FDA grants priority review to therapies that have the potential to provide significant improvements in the treatment, diagnosis, or prevention of serious conditions. Efanesoctocog alfa received Breakthrough Therapy designation from the FDA in
Regulatory submission in the EU will follow availability of data from the ongoing XTEND-Kids paediatric study, with both events expected in 2023. The
About haemophilia A
Haemophilia A is a rare, genetic disorder in which the ability of a person's blood to clot is impaired due to a lack of factor VIII. Haemophilia A occurs in about one in 5,000 male births annually, and more rarely in females. People with haemophilia can experience bleeding episodes that can cause pain, irreversible joint damage and life-threatening haemorrhages. Factor replacement therapy remains a cornerstone of care and can be used across multiple treatment scenarios.
About efanesoctocog alfa (BIVV001)
Efanesoctocog alfa is a novel and investigational recombinant factor VIII therapy that is designed to extend protection from bleeds with once-weekly prophylactic dosing for people with haemophilia A. It builds on the innovative Fc fusion technology by adding a region of von Willebrand factor and XTEN® polypeptides to extend its time in circulation. It is the first investigational factor VIII therapy that has been shown to break through the von Willebrand factor ceiling, which imposes a half-life limitation on current factor VIII therapies. Efanesoctocog alfa is currently under clinical investigation and its safety and efficacy have not been evaluated by any regulatory authority.
About the
Sobi and
About
We are an innovative global healthcare company, driven by one purpose: we chase the miracles of science to improve people's lives. Our team, across some 100 countries, is dedicated to transforming the practice of medicine by working to turn the impossible into the possible. We provide potentially life-changing treatment options and life-saving vaccine protection to millions of people globally, while putting sustainability and social responsibility at the centre of our ambitions.
Sobi®
Sobi is a specialised international biopharmaceutical company transforming the lives of people with rare diseases. Providing sustainable access to innovative medicines in the areas of haematology, immunology and specialty care, Sobi has approximately 1,600 employees across
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