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The European Commission (EC) has approved the recombinant factor VIII Fc fusion protein efmoroctocog alfa (Elocta) to treat patients with hemophilia A in the European Union (EU) as well as Iceland, Liechtenstein, and Norway.
Efmoroctocog alfa is indicated for both on-demand and prophylactic treatment of hemophilia A in patients of all ages.
Research has shown that efmoroctocog alfa has an extended half-life compared to recombinant factor VIII.
Efmoroctocog alfa will be the first hemophilia A treatment in the EU to offer prolonged protection against bleeding episodes with prophylactic injections every 3 to 5 days.
The product is expected to launch in initial EU countries in early 2016.
The EC’s approval of efmoroctocog alfa was based on data from 2 phase 3 studies: A-LONG and Kids A-LONG.
A-LONG
The A-LONG study included 165 previously treated males 12 years of age and older with severe hemophilia A. Researchers evaluated individualized and weekly prophylaxis to reduce or prevent bleeding episodes and on-demand dosing to treat bleeding episodes.
Prophylaxis with efmoroctocog alfa resulted in low annualized bleeding rates, and a majority of bleeding episodes were controlled with a single injection of efmoroctocog alfa.
None of the patients developed neutralizing antibodies, efmoroctocog alfa was considered well-tolerated, and the product had a prolonged half-life when compared with recombinant factor VIII.
Kids A-LONG
The Kids A-LONG study included 71 boys (younger than 12) with severe hemophilia A who had at least 50 prior exposure days to factor VIII therapies.
The children saw their median annualized bleeding rate decrease with efmoroctocog alfa, and close to half of the children did not have any bleeding episodes while they were receiving efmoroctocog alfa.
None of the patients developed inhibitors, and researchers said adverse events were typical of a pediatric hemophilia population.
ASPIRE
Participants in both the A-LONG and Kids A-LONG trials were able to enroll in ASPIRE, a phase 3 extension study evaluating the long-term safety and efficacy of efmoroctocog alfa.
Interim results of ASPIRE suggested that extended treatment with efmoroctocog alfa was largely safe and effective.
About efmoroctocog alfa
Efmoroctocog alfa was developed by fusing B-domain deleted factor VIII to the Fc portion of immunoglobulin G subclass 1. It is believed that this enables efmoroctocog alfa to utilize a naturally occurring pathway to prolong the time the therapy remains in the body.
Sobi and Biogen are collaborators in the development and commercialization of efmoroctocog alfa for hemophilia A.
Last year, Sobi exercised its opt-in right to assumeefmoroctocog alfa’s final development and commercialization in pre-specified territories, which includes Europe, North Africa, Russia, and certain countries in the Middle East.
Biogen leads development and manufacturing of the product and holds commercialization rights in North America and all other regions in the world outside of the Sobi territories.
Elocta is the trade name for efmoroctocog alfa in Sobi’s territory. The product is approved under the name Eloctate (Antihemophilic Factor [Recombinant], Fc Fusion Protein) in the US, Canada, Australia, New Zealand, and Japan. 
The European Commission (EC) has approved the recombinant factor VIII Fc fusion protein efmoroctocog alfa (Elocta) to treat patients with hemophilia A in the European Union (EU) as well as Iceland, Liechtenstein, and Norway.
Efmoroctocog alfa is indicated for both on-demand and prophylactic treatment of hemophilia A in patients of all ages.
Research has shown that efmoroctocog alfa has an extended half-life compared to recombinant factor VIII.
Efmoroctocog alfa will be the first hemophilia A treatment in the EU to offer prolonged protection against bleeding episodes with prophylactic injections every 3 to 5 days.
The product is expected to launch in initial EU countries in early 2016.
The EC’s approval of efmoroctocog alfa was based on data from 2 phase 3 studies: A-LONG and Kids A-LONG.
A-LONG
The A-LONG study included 165 previously treated males 12 years of age and older with severe hemophilia A. Researchers evaluated individualized and weekly prophylaxis to reduce or prevent bleeding episodes and on-demand dosing to treat bleeding episodes.
Prophylaxis with efmoroctocog alfa resulted in low annualized bleeding rates, and a majority of bleeding episodes were controlled with a single injection of efmoroctocog alfa.
None of the patients developed neutralizing antibodies, efmoroctocog alfa was considered well-tolerated, and the product had a prolonged half-life when compared with recombinant factor VIII.
Kids A-LONG
The Kids A-LONG study included 71 boys (younger than 12) with severe hemophilia A who had at least 50 prior exposure days to factor VIII therapies.
The children saw their median annualized bleeding rate decrease with efmoroctocog alfa, and close to half of the children did not have any bleeding episodes while they were receiving efmoroctocog alfa.
None of the patients developed inhibitors, and researchers said adverse events were typical of a pediatric hemophilia population.
ASPIRE
Participants in both the A-LONG and Kids A-LONG trials were able to enroll in ASPIRE, a phase 3 extension study evaluating the long-term safety and efficacy of efmoroctocog alfa.
Interim results of ASPIRE suggested that extended treatment with efmoroctocog alfa was largely safe and effective.
About efmoroctocog alfa
Efmoroctocog alfa was developed by fusing B-domain deleted factor VIII to the Fc portion of immunoglobulin G subclass 1. It is believed that this enables efmoroctocog alfa to utilize a naturally occurring pathway to prolong the time the therapy remains in the body.
Sobi and Biogen are collaborators in the development and commercialization of efmoroctocog alfa for hemophilia A.
Last year, Sobi exercised its opt-in right to assumeefmoroctocog alfa’s final development and commercialization in pre-specified territories, which includes Europe, North Africa, Russia, and certain countries in the Middle East.
Biogen leads development and manufacturing of the product and holds commercialization rights in North America and all other regions in the world outside of the Sobi territories.
Elocta is the trade name for efmoroctocog alfa in Sobi’s territory. The product is approved under the name Eloctate (Antihemophilic Factor [Recombinant], Fc Fusion Protein) in the US, Canada, Australia, New Zealand, and Japan.
The European Commission (EC) has approved the recombinant factor VIII Fc fusion protein efmoroctocog alfa (Elocta) to treat patients with hemophilia A in the European Union (EU) as well as Iceland, Liechtenstein, and Norway.
Efmoroctocog alfa is indicated for both on-demand and prophylactic treatment of hemophilia A in patients of all ages.
Research has shown that efmoroctocog alfa has an extended half-life compared to recombinant factor VIII.
Efmoroctocog alfa will be the first hemophilia A treatment in the EU to offer prolonged protection against bleeding episodes with prophylactic injections every 3 to 5 days.
The product is expected to launch in initial EU countries in early 2016.
The EC’s approval of efmoroctocog alfa was based on data from 2 phase 3 studies: A-LONG and Kids A-LONG.
A-LONG
The A-LONG study included 165 previously treated males 12 years of age and older with severe hemophilia A. Researchers evaluated individualized and weekly prophylaxis to reduce or prevent bleeding episodes and on-demand dosing to treat bleeding episodes.
Prophylaxis with efmoroctocog alfa resulted in low annualized bleeding rates, and a majority of bleeding episodes were controlled with a single injection of efmoroctocog alfa.
None of the patients developed neutralizing antibodies, efmoroctocog alfa was considered well-tolerated, and the product had a prolonged half-life when compared with recombinant factor VIII.
Kids A-LONG
The Kids A-LONG study included 71 boys (younger than 12) with severe hemophilia A who had at least 50 prior exposure days to factor VIII therapies.
The children saw their median annualized bleeding rate decrease with efmoroctocog alfa, and close to half of the children did not have any bleeding episodes while they were receiving efmoroctocog alfa.
None of the patients developed inhibitors, and researchers said adverse events were typical of a pediatric hemophilia population.
ASPIRE
Participants in both the A-LONG and Kids A-LONG trials were able to enroll in ASPIRE, a phase 3 extension study evaluating the long-term safety and efficacy of efmoroctocog alfa.
Interim results of ASPIRE suggested that extended treatment with efmoroctocog alfa was largely safe and effective.
About efmoroctocog alfa
Efmoroctocog alfa was developed by fusing B-domain deleted factor VIII to the Fc portion of immunoglobulin G subclass 1. It is believed that this enables efmoroctocog alfa to utilize a naturally occurring pathway to prolong the time the therapy remains in the body.
Sobi and Biogen are collaborators in the development and commercialization of efmoroctocog alfa for hemophilia A.
Last year, Sobi exercised its opt-in right to assumeefmoroctocog alfa’s final development and commercialization in pre-specified territories, which includes Europe, North Africa, Russia, and certain countries in the Middle East.
Biogen leads development and manufacturing of the product and holds commercialization rights in North America and all other regions in the world outside of the Sobi territories.
Elocta is the trade name for efmoroctocog alfa in Sobi’s territory. The product is approved under the name Eloctate (Antihemophilic Factor [Recombinant], Fc Fusion Protein) in the US, Canada, Australia, New Zealand, and Japan.