Medically known as efmoroctocog alfa, Elocta was granted EU Marketing Authorisation in December 2015 and is a recombinant human factor VIII Fc fusion protein with an extended half-life.
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 launch of Elocta is an important milestone for the haemophilia community in the UK, offering people with haemophilia A a treatment option that provides extended protection against bleeds”, said Neil Dugdale, General Manager UK 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 in the UK. Whilst we await the potential inclusion of Elocta within a National Framework agreement by mid year, we are delighted to be able to announce that the Elocta is now available for sale via our distributor Alloga UK.”
The SmPC recommended prophylactic dose of Elocta is 50 IU/ kg every three to five days. The dose may be personalized 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.
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 3 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 3 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.
Haemophilia A is a rare, chronic, genetic disorder in which the ability of a person’s blood to clot is impaired due to missing or reduced levels of a protein known as factor VIII. People with haemophilia A experience bleeding episodes that may cause pain, irreversible joint damage and life-threatening haemorrhages. According to the World Federation of Hemophilia, an estimated 140,000 people worldwide are identified as living with haemophilia A of which an estimated 5,000 people are in the UK.