SWEDISH ORPHAN BIOVITRUM AB Sobi® will present new scientific data related to haemophilia at ISTH 2024, the 32ndCongress of the International Society on Thrombosis and Haemostasis. This event, taking place from 22ndto 26thJune, will be held both online and in Bangkok. Seven abstracts have been accepted for presentation (three posters and four oral). New long-term safety and efficacy data on efanesoctocog alfa and long-term efficacy data on Elocta will be presented further demonstrating Sobi's commitment to advancing standards of care in haemophilia A treatment.
"We are pleased to present new data at this year's ISTH regarding the impact of efanesoctocog alfa on joint-health, perioperative management and long-term outcomes of keeping the patient in the non-haemophilia range for most of the week," saidLydia Abad-Franch, MD, Head of R&D and Medical Affairs, and Chief Medical Officer at Sobi. "These positive study outcomes highlight Sobi's commitment toengaging in collaborative research to support the community and improvecare for people with haemophilia around the world."
Key data to be presented at ISTH 2024
Haemophilia | ||
Efanesoctocog alfa - Sobi/Sanofi | Interim analysis of joint outcomes in adult and adolescent patients with severe haemophilia A receiving efanesoctocog alfa during the phase 3 XTEND-ed long-term extension study | Oral Presentation. #OC 01.4
22 June |
Efanesoctocog alfa - Sobi/Sanofi | Perioperative management with efanesoctocog alfa in adults, adolescents, and children with severe haemophilia A in the phase 3 XTEND clinical program | Oral Presentation.
#OC 14.1 |
Efanesoctocog alfa - Sobi/Sanofi | Long-term outcomes with efanesoctocog alfa prophylaxis for previously treated children with severe haemophilia A, an interim analysis of the phase 3 XTEND-ed study |
Oral Presentation
25 June |
Efanesoctocog alfa - Sobi/Sanofi | First interim analysis of clinical outcomes in adults and adolescents with severe haemophilia A receiving efanesoctocog alfa prophylaxis in XTEND-ed, a phase 3 long-term extension study |
Oral Presentation.
25 June |
Elocta®/Eloctate® (efmoroctocog alfa) - Sobi | Long-term joint health outcomes with a recombinant factor VIII Fc from the 48-month prospective, observational A-MORE study: Third interim analysis of up to 24 months | Poster presentation. #PB0505 24 June 13:45 - 14:45 ITC |
Elocta®/Eloctate® (efmoroctocog alfa) - Sobi | Effectiveness and safety of efmoroctocog alfa (a recombinant factor VIII Fc) across body mass index (BMI) categories: Pooled data from two non-interventional phase 4 studies (A-SURE/PREVENT) |
Poster presentation.
23 June |
General Haemophilia | Using theHemophilia Functional Ability Scoring Tool(Hemo-FAST) to describe the joint health status in adults with hemophilia | Poster presentation. #PB1227 25 June 13:45 - 14:45 ITC |
All abstracts are accessible through the official ISTH website. However, any late-breaking abstracts will only be made available later.
About Elocta®/Eloctate®
Elocta®/Eloctate® (efmoroctocog alfa) is a recombinant clotting factor therapy developed for haemophilia A using Fc fusion technology to prolong circulation in the body. It is engineered by fusing factor VIII to the Fc portion of immunoglobulin G subclass 1, or IgG1 (a protein commonly found in the body), enabling Elocta to use a naturally occurring pathway to extend the time the therapy remains in the body (half-life). Elocta is manufactured using a human cell line in an environment free of animal and human additives. Elocta is approved and marketed by Sobi for the treatment of haemophilia A in the EU, the UK, Iceland, Kuwait, Liechtenstein, Norway, Saudi Arabia and Switzerland. It is approved and marketed as Eloctate® (Antihemophilic Factor [Recombinant], Fc Fusion Protein) by Sanofi in the United States, Canada Japan, Australia, New Zealand and other countries, where Sanofi has the marketing rights.
About efanesoctocog alfa
Efanesoctocog alfa [Antihemophilic Factor (Recombinant), Fc-VWF-XTEN Fusion Protein] (formerly BIVV001) is a high-sustained FVIII recombinant factor VIII therapy with the potential to sustain FVIII levels in non-haemophilia range (>40%) for a significant part of the week, improving bleed protection in a once-weekly dose for people with haemophilia A. Efanesoctocog alfa 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 only therapy that has been shown to break through the von Willebrand factor ceiling, which imposes a half-life limitation on current factor VIII therapies. It is approved and marketed as ALTUVIIIO™ [Antihemophilic Factor (Recombinant), Fc-VWF-XTEN Fusion Protein-ehtl] by Sanofi in the United States, Japan, and Taiwan. The European Commission granted Orphan Drug designation in June 2019. The Committee for Medicinal Products for Human Use of the European Medicines Agency issued a positive opinion recommending approval of efanesoctocog alfa for the treatment and prevention of bleeds and perioperative prophylaxis in haemophilia A in April 2024.
About the Sanofi and Sobi collaboration
Sobi and Sanofi collaborate on the development and commercialisation of Alprolix® and Elocta®/Eloctate®. The companies also collaborate on the development and commercialisation of efanesoctocog alfa, or ALTUVIIIO™ in the US. Sobi has final development and commercialisation rights in the Sobi territory (essentially Europe, North Africa, Russia, and most Middle Eastern markets). Sanofi has final development and commercialisation rights in North America and all other regions in the world excluding the Sobi territory.
About Sanofi
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. Sanofi is listed on EURONEXT: SAN and NASDAQ: SNY
About Sobi®
Sobi® is a specialised international biopharmaceutical company transforming the lives of people with rare and debilitating diseases. Providing reliable access to innovative medicines in the areas of haematology, immunology, and specialty care, Sobi has approximately 1,800 employees across Europe, North America, the Middle East, Asia, and Australia. In 2023, revenue amounted to SEK 22.1 billion. Sobi's share (STO:SOBI) is listed on Nasdaq Stockholm. More about Sobi at sobi.com and LinkedIn.
Contacts
For details on how to contact the Sobi Investor Relations Team, please click here. For Sobi Media contacts, click here.
Swedish Orphan Biovitrum AB (publ)
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Phone: 46 8 697 20 00 https://www.sobi.com
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Swedish Orphan Biovitrum AB published this content on 17 June 2024 and is solely responsible for the information contained therein. Distributed by Public, unedited and unaltered, on 17 June 2024 06:03:04 UTC.
