Swedish Orphan Biovitrum today announces that the company’s product Elocta®, a recombinant human factor VIII Fc-fusion protein with an extended half-life for the treatment of haemophilia A, has been approved for reimbursement in the UK, Italy and France.
Swedish Orphan Biovitrum AB: (STO:SOBI) Patient access to Elocta is increasing, contributing to further evidence generation and real-world patient experience for extended half-life factor VIII therapy
Swedish Orphan Biovitrum (Sobi™) (http://www.sobi.com/)
today announces that the company’s product Elocta® (efmoroctocog alfa),
a recombinant human factor VIII Fc-fusion protein with an extended
half-life for the treatment of haemophilia A, has been approved for
reimbursement in the UK, Italy and France. These countries join Germany,
Sweden, Denmark, Norway, Switzerland, the Netherlands, Slovenia and the
Republic of Ireland where Elocta is already available.
This expansion in availability is supported by global experience. With
more than two years of post-authorisation real-world experience with
Elocta (marketed as Eloctate® in the US and other regions), over 2,700
patients have been treated in countries where Elocta is commercially
available, corresponding to about 1,800 patient-years of experience.
“This extensive post approval clinical experience with Elocta
complements the clinical data generated by our pivotal clinical studies,
and follows the findings of the long term ASPIRE extension study. We
believe that this comprehensive clinical data and real world experience
can provide support to clinicians and patients while making their
treatment choices as Elocta becomes available in additional countries,”
said Krassimir Mitchev, MD, PhD, Vice President and medical therapeutic
area head of Haemophilia at Sobi.
The safety and efficacy of long-term use of the extended half-life
recombinant Fc-factor VIII, Elocta for haemophilia A were highlighted in
a series of oral and poster presentations by Biogen and Sobi at the
World Federation of Hemophilia (WFH) 2016 World Congress in Orlando,
Florida that took place 24-28 July 2016.
Through the pivotal clinical trials (A-LONG, Kids A-LONG) and extension
study (ASPIRE) 233 patients have been treated with Elocta. Overall
clinical study experience with Elocta confirms its long term safety and
efficacy, and supports its potential to offer extended protection
Eloctate was first approved for haemophilia A in the USA in June 2014
and in the EU (as Elocta) in November 2015.
A Haemophilia is a rare, genetic disorder in which the ability of a
person’s blood to clot is impaired. Haemophilia A occurs in about one in
5,000 male births annually, and more rarely in females.
People with haemophilia A experience prolonged bleeding episodes that
can cause pain, irreversible joint damage and life-threatening
haemorrhages. Prophylactic infusions of factor VIII can temporarily
replace the missing clotting factors that are needed to control bleeding
and prevent new bleeding episodes.[i] (http://teamsites.sobi.com/s/corporate-communications/Shared%20Documents/Press%20releases/041_WFH%20real%20world%20data/041e_TAH%20real%20world%20experience_final.docx#_edn1)
The World Federation of Hemophilia recommends prophylaxis as the optimal
therapy as it can prevent bleedings and joint destruction.[ii] (http://teamsites.sobi.com/s/corporate-communications/Shared%20Documents/Press%20releases/041_WFH%20real%20world%20data/041e_TAH%20real%20world%20experience_final.docx#_edn2)
Elocta (efmoroctocog alfa), the first recombinant clotting factor VIII
therapy that offers an extended half-life in the body, is approved in
the European Union, Switzerland, Iceland, Liechtenstein and Norway, as
well as the United States, Canada, Australia, New Zealand and Japan (as
Eloctate). It was developed for haemophilia A by fusing factor VIII to
the Fc portion of immunoglobulin G subclass 1, or IgG1 (a protein
commonly found in the body). This enables Elocta to use a naturally
occurring pathway to prolong the time the therapy remains in the body.
While Fc fusion technology has been used for more than 15 years, Sobi
and Biogen are the first companies to utilise it in the treatment of
As with any factor replacement therapy, development of inhibitors may
occur following administration of Elocta/Eloctate.
About Sobi™ Sobi is an international specialty healthcare company
dedicated to rare diseases. Sobi’s mission is to develop and deliver
innovative therapies and services to improve the lives of patients. The
product portfolio is primarily focused on Haemophilia, Inflammation and
Genetic diseases. Sobi also markets a portfolio of specialty and rare
disease products across Europe, the Middle East, North Africa and Russia
for partner companies. Sobi is a pioneer in biotechnology with
world-class capabilities in protein biochemistry and biologics
manufacturing. In 2015, Sobi had total revenues of SEK 3.2 billion (USD
385 M) and about 700 employees. The share (STO: SOBI) is listed on
Nasdaq Stockholm. More information is available at www.sobi.com.
World Federation of Hemophilia. About Bleeding Disorders – Frequently
Asked Questions. Available at: http://www.wfh.org/en/page.aspx?pid=637#Difference_A_B.
Accessed on: June 17, 2016.
Guideline for the management of hemophilia, World Federation of
Hemophilia, 2nd edition, http://www1.wfh.org/publication/files/pdf-1472.pdf.
Accessed December 2015 (http://www1.wfh.org/publication/files/pdf-1472.pdf.%20Accessed%20December%202015)
Swedish Orphan Biovitrum AB
Postal address SE-112 76 Stockholm, Sweden
Phone: +46 8 697 20 00 www.sobi.com
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