Swedish Orphan Biovitrum AB has announced the commercial launch of Elocta® (efmoroctocog alfa) in first countries in Europe.
Elocta is a recombinant human factor VIII Fc fusion protein with an extended half-life, and is the first haemophilia A treatment in the EU to offer prolonged protection against bleeding episodes with prophylactic injections every three to five days.
Elocta is indicated for both prophylaxis and on-demand treatment of bleeding in people with haemophilia A and can be used for all age groups. The SmPC recommended prophylactic dose of Elocta is 50 IU/kg every three to five days. The dose may be personalised by the treating physician in the range of 25 to 65 IU/kg depending on the severity of the factor VIII deficiency, the location and frequency of bleeding, and the patient’s activity level and clinical condition.
“The launch of Elocta is an important milestone for the haemophilia community, offering people with haemophilia A in the EU a treatment option that provides extended protection against bleeds“, said Geoffrey McDonough, CEO and President at Sobi. “Since the approval of Elocta in the EU, our focus has been to ensure timely and sustainable access to Elocta for people living with haemophilia A. We are delighted to be able to announce that Elocta is now available.”
Elocta is a fully recombinant fusion protein produced from a human cell line without the addition of human- or animal-derived protein. The European Commission’s approval of Elocta was based on data from the pivotal Phase III A-LONG clinical study which demonstrated the efficacy, safety and pharmacokinetics of Elocta in previously treated males 12 years of age and older with severe haemophilia A, and from the Phase III Kids A-LONG clinical study, which demonstrated the efficacy and safety of Elocta in previously treated boys under 12 years of age with haemophilia A.
“Low annualised bleeding rates, comparable with those seen in the pivotal A-LONG and Kids A-LONG trials, have been observed during the ongoing open label, long term follow-up ASPIRE study, with most participants receiving prophylactic treatment with similar weekly Elocta consumption as in the pivotal Phase III studies“, said Birgitte Volck, Senior Vice President, Chief Medical Officer at Sobi. “For long term prophylaxis Elocta offers a dosing regimen that can be personalised to meet the needs of each individual patient.”
Sobi and Biogen are collaboration partners in the development and commercialisation of Elocta for haemophilia A, which is also known as Eloctate® (Antihemophilic Factor (Recombinant), Fc Fusion Protein) in Australia, Canada, Japan, New Zealand and the US, where it is approved for the treatment of haemophilia A. Sobi holds final development and commercialisation rights in pre-specified territories, which include Europe, North Africa, Russia and certain countries in the Middle East. Biogen leads development and manufacturing of the product and holds commercialisation rights in North America and all other regions in the world outside of the Sobi territory.