A Comparison Between Recombinant Activated Factor VII (Aryoseven) and Novoseven in Patients With Congenital Factor VII Deficiency

Abstract

In order to establish the efficacy and biosimilar nature of AryoSeven to NovoSeven in the treatment of congenital factor VII (FVII) deficiency, patients received either agent at 30 μg/kg, intravenously per week for 4 weeks, in a randomized fashion. The primary aim was to compare FVII:coagulation activity (FVII:C), 20 minutes after recombinant activated FVII (rFVIIa) injection, in the 2 groups. A secondary measure was self-reported bleeding. The median interquartile baseline range of the plasma level of activated FVII (FVIIa) activity in the 2 groups was 1.6 (1.1-14.0) IU/dL and 5.0 (1.1-25.5) IU/dL. All patients achieved levels of FVIIa (FVII:C) >30 IU/dL, 20 minutes after the injection of rFVIIa. Bleeding was similar between the 2 groups, with a comparable decrease in severity and frequency compared to the last month prior to treatment. AryoSeven is similar to NovoSeven in increasing postinjection FVIIa activity as well as in clinical safety and efficacy.

Diagnosis, clinical manifestations and management of rare bleeding disorders in Iran

“…Different therapeutic choices, including FFP, prothrombin complex concentrate (PCC), and recombinant FVII (rFVII), are available for Iranian patients with FVIID. Recently, an Iranian rFVII (Aryoseven) was produced and successfully used in Iranian patients [16][17][18]26,37,38,40].…”

Successful Control of Massive Bleeding in a Child with Burkitt’s Lymphoma via a Biosimilar Recombinant Activated Factor VII (AryoSeven™)

“…AryoSeven is an rFVIIa recently manufactured via recombinant technology in Iran by AryoGen pharmed. It has been proved similar to its originator medicine, NovoSeven® [3]. …”

A Comparison of Efficacy Between Recombinant Activated Factor VII (Aryoseven) and Novoseven in Patients With Hereditary FVIII Deficiency With Inhibitor

“…45,46 In March 1999, Novoseven received Food and Drug Administration approval letter to be used for treatment of bleeding episodes in patients with hemophilia A or B with inhibitors to FVIII or factor IX. 40,47 Aryoseven is a biosimilar version of Novoseven. 40 In this study, we compared therapeutic outcome, side effects, and safety of rFVIIa product (Aryoseven) with Novoseven in patients with hemophilia A with inhibitor.…”

“…45,46 In March 1999, Novoseven received Food and Drug Administration approval letter to be used for treatment of bleeding episodes in patients with hemophilia A or B with inhibitors to FVIII or factor IX. 40,47…”