Swedish Orphan Biovitrum

Sobi to present new data at EAHAD 2024

“We are proud to showcase new data at EAHAD 2024, including several new data sets that add to the substantial evidence supporting the use of efanesoctocog alfa in children and highlighting improvements in patient-reported outcomes. Our hope is that these advancements will open new possibilities for people with haemophilia,” said Lydia Abad-Franch, Head of R&D and Chief Medical Officer at Sobi. "We will also present further data reinforcing the comprehensive evidence supporting the safety and effectiveness of Elocta® and Alprolix®. Sobi's involvement at EAHAD underscores our continued dedication to advancing knowledge and raising standards of care.”
 

Key Sobi data to be presented at EAHAD 2024

Efanesoctocog Alfa – Joint Sobi/Sanofi

Effective protection with once-weekly efanesoctocog alfa in children: Secondary analyses of pharmacokinetics and bleeds from the XTEND-Kids trial

Oral presentation number: OR12

Efanesoctocog Alfa – Joint Sobi/Sanofi

Efanesoctocog Alfa Prophylaxis Outcomes in European Patients From the XTEND-1 Trial

Poster presentation number:
PO113
 

Efanesoctocog Alfa – Joint Sobi/Sanofi

Clinical overview of perioperative outcomes from the XTEND-Kids study 

Poster presentation number:

PO050
 

Efanesoctocog Alfa – Joint Sobi/Sanofi

Treatment Preferences in Previously Treated Patients with Haemophilia A: Phase 3 XTEND-1 Study of Efanesoctocog Alfa 

Poster presentation number:
PO123
 

Efanesoctocog Alfa – Joint Sobi/Sanofi

Quality of Life in Children with Haemophilia A: Phase 3 XTEND-Kids Study of Efanesoctocog Alfa 

Poster presentation number:
PO134
 

Efanesoctocog Alfa – Joint Sobi/Sanofi

Systematic literature review to evaluate haemophilia A therapies in paediatric patients without inhibitors

Poster presentation number:
PO184
 

Elocta®/Eloctate® (efmoroctocog alfa) – Sobi

Immune Tolerance Induction with a Recombinant Factor VIII Fc in Haemophilia A: Final Data from a Chart Review Study 

Poster presentation number:
PO103

Elocta®/Eloctate® (efmoroctocog alfa) – Sobi

Real-world effectiveness and safety of a recombinant Factor VIII Fc in patients with haemophilia A by age groups: Pooled analysis (A-SURE/PREVENT) 

Poster presentation number:
PO085

Elocta®/Eloctate® (efmoroctocog alfa) – Sobi

Real-world effectiveness and safety of a recombinant Factor VIII Fc in patients with haemophilia A by disease severity: Pooled analysis (A-SURE/PREVENT)

Poster presentation number:
PO099

Alprolix® (eftrenonacog alfa)
– Sobi

Real-World Effectiveness and Usage of Recombinant Factor IX Fc: Secondary Paediatric Analysis from the 24-Month French, Prospective, Non-Interventional B-SURE Study 

Poster presentation number:
PO068

Alprolix® (eftrenonacog alfa)
– Sobi

Interim Analysis of Real-World Effectiveness and Usage of Recombinant Factor IX Fc for Surgical Haemostasis from the 24-Month Prospective, Non-Interventional B-MORE Study 

Poster presentation number:
PO043

Alprolix® (eftrenonacog alfa)
– Sobi

Real-World Effectiveness and Usage of Recombinant Factor IX Fc: Interim Analysis in Paediatric Patients from the 24-Month, Prospective, Non-Interventional B-MORE Study 

Poster presentation number:
PO127

Haemophilia

Physical Activity Awareness Among People with Haemophilia and their Caregivers in Central Europe 

Poster presentation number:
PO299
Session date and time:

6 February 2024, from 12:00 to 20:30

 

All presentations can be accessed via the official EAHAD 2024 website.

About efanesoctocog alfa 

Efanesoctocog alfa [Antihemophilic Factor (Recombinant), Fc-VWF-XTEN Fusion Protein] (formerly BIVV001) is a new class and investigational recombinant factor VIII therapy with the potential to deliver near-normal factor activity levels for a significant parts 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, and the European Medicines Agency accepted the Marketing Authorisation Application (MAA) for efanesoctocog alfa in May 2023.

 

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 Alprolix®
Alprolix® (eftrenonacog alfa) is a recombinant clotting factor therapy developed for haemophilia B using Fc fusion technology to prolong circulation in the body. It is engineered by fusing factor IX to the Fc portion of immunoglobulin G subclass 1, or IgG1 (a protein commonly found in the body), enabling Alprolix to use a naturally occurring pathway to extend the time the therapy remains in the body (half-life). Alprolix is manufactured using a human cell line in an environment free of animal and human additives. Alprolix is approved and marketed by Sobi for the treatment of haemophilia B in the EU, the UK, Iceland, Kuwait, Liechtenstein, Norway, Saudi Arabia and Switzerland. It is also approved in the United States, Canada, Japan, Australia, New Zealand and other countries where Sanofi has the marketing rights.

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.
 

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 2022, revenue amounted to SEK 18.8 billion. Sobi's share (STO:SOBI) is listed on Nasdaq Stockholm. More about Sobi at sobi.com, LinkedIn and YouTube.

Contacts
For details on how to contact the Sobi Investor Relations Team, please click here. For Sobi Media contacts, click here.

Datum 2024-01-31, kl 07:00
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