Product Dossier
ESPEROCT
Product Dossier for ESPEROCT (turoctocog alfa pegol, Novo Nordisk Pharmaceuticals). ARTG record, PBS listing, PBAC outcomes, AusPAR — compiled by…
- Sponsor: Novo Nordisk Pharmaceuticals
- Active ingredient: turoctocog alfa pegol
- Therapeutic area: Haematology
- Same area: REVOLADE
- Same area: NOVICRIT
What it is
Esperoct is a long-acting recombinant Factor VIII concentrate indicated for use in previously treated patients with haemophilia A. Esperoct does not contain von Willebrand factor, and therefore is not indicated in patients with von Willebrand's disease.
Approved indications —
Routine prophylactic treatment to prevent or reduce the frequency of bleeding episodes in previously treated patients with haemophilia A. — On-demand treatment and control of bleeding episodes in previously treated patients with haemophilia A. — Peri-operative management of bleeding (surgical prophylaxis) in previously treated patients with haemophilia A.
Regulatory history
Esperoct was approved by the TGA on 31 May 2023 for the treatment and prophylaxis of bleeding in previously treated patients with haemophilia A. This decision followed a positive overall benefit-risk assessment, despite some initial concerns about data integrity during overseas evaluations. The TGA's evaluation, largely based on overseas regulator reports, found that Esperoct's clinical data supported its efficacy and safety for the proposed indications in previously treated patients with haemophilia A, and despite initial concerns regarding data quality and integrity identified during EMA inspections, the data was ultimately deemed reliable enough to support the application. ESPEROCT turoctocog alfa pegol in strengths of 500 IU, 1000 IU, 1500 IU, 2000 IU and 3000 IU powder for injection vial with solvent were first listed on the ARTG on 5 June 2023.