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First Patients Enrolled in 24 Month Real-world Study Evaluating Swedish Orphan Biovitrum's Elocta.

M2 PHARMA-January 20, 2017-First Patients Enrolled in 24 Month Real-world Study Evaluating Swedish Orphan Biovitrum's Elocta

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- The first patients have been enrolled in Swedish specialty healthcare company Swedish Orphan Biovitrum AB's A-SURE study (NCT02976753).

A-SURE is a 24-month real-world study evaluating the effectiveness of Elocta compared to conventional FVIII products in the prophylactic treatment of patients with haemophilia A in Europe.

The efficacy and safety of Elocta have been established in clinical trials and the A-SURE study will provide data from a real-world setting, which can be made available to physicians, payers and reimbursement authorities in evaluating the effectiveness and usage of Elocta.

Clinical data shows that effective bleed prevention can be achieved with Elocta with extended dosing intervals.

A-SURE is a study that aims to evaluate the effectiveness of Elocta in a real world-setting.

Sobi is committed to providing data to the haemophilia community on the potential opportunities Elocta can provide to the people living with haemophilia A," says Stefan Lethagen, vice president Medical and Clinical Sciences, Haemophilia at Sobi.

The A-SURE study plans to enrol 350 patients in around 10 countries in Europe.

The purpose of the A-SURE multicentre, non-interventional study is to evaluate the effectiveness of Elocta compared to conventional factor products in the prophylactic treatment of patients with haemophilia A over a 24-month prospective period.

Data will also be collected for a 12-month retrospective period.

Elocta (efmoroctocog alfa) is a recombinant clotting factor VIII therapy developed for haemophilia A with prolonged circulation in the body using Fc fusion technology.

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.

While Fc fusion technology has been used for more than 15 years, Sobi and Biogen have optimised the technology and are the first companies to utilise it in the treatment of haemophilia. Elocta is manufactured in a human cell line, using an environment free of animal and human additives.

Elocta is approved for the treatment of haemophilia A in the European Union, Switzerland, Iceland, Liechtenstein, Norway and Kuwait, marketed by Sobi; and, in the United States, Japan, Canada, Australia, New Zealand, Brazil and other countries is approved as Eloctate. Biogen has the marketing rights in these regions.

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Publication:M2 Pharma
Date:Jan 20, 2017
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