Swedish Orphan Biovitrum AB recently announced that Eloctate (efmoroctocog alfa; brand name Elocta in Europe), a treatment for hemophilia A, has been approved for reimbursement in the United Kingdom, Italy, and France. These countries join others in the European Union — Germany, Sweden, Denmark, Norway, Switzerland, the Netherlands, Slovenia, and the Republic of Ireland — where the treatment is already available.
Eloctate is a recombinant clotting factor VIII therapy that treats hemophilia A by fusing that factor to the Fc portion of immunoglobulin G subclass 1, a common protein also known as IgG1. The treatment is indicated in adults and children with hemophilia A (congenital Factor VIII deficiency) for on-demand treatment and control of bleeding episodes, perioperative management of bleeding, and routine prophylaxis to reduce the frequency of bleeding episodes.
The treatment was approved in the U.S. in June 2014, and in the E.U. (as Elocta) in November 2015.
In the two or so years of since its approval and commercial availability, Eloctate has treated more than 2,700 patients, corresponding to about 1,800 patient-years of experience, the company stated in a press release.
“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,” Krassimir Mitchev, MD, PhD, vice president and medical therapeutic area head of Haemophilia at Sobi said in the release.
The safety, efficacy and prolonged half-life of Eloctate in previously treated patients with severe hemophilia A has been demonstrated in the Phase 3 A-LONG (NCT02234323) and Kids A-LONG (NCT01458106; completed) studies and in the extension study, ASPIRE (NCT01454739) in which, the company reported, 233 patients were treated with Eloctate. The results were found to confirm the long-term safety of the treatment and the maintenance of a low annualized bleed rate in patients with severe hemophilia A. The A-LONG study is still enrolling previously untreated patients, up to age 5, at 45 study sites in the U.S., Brazil, Canada, and across Europe; more information is available on its clinical trials.gov website.
Biogen and Sobi recently presented updated and long-term efficacy and safety data on Eloctate for the treatment of hemophilia A at the World Federation of Hemophilia (WFH)’s 2016 World Congress.