Esperoct, Zonovate Now Available in Canada to Prevent Bleeds in Hem A
The therapies have been accessible through Canadian Blood Services since April 1.
“As part of our continued commitment to provide support to Canadians living with rare diseases, we are pleased to expand our product portfolio across Canada to address individual patient needs,” John Burrows, vice president of rare disease at Novo Nordisk Canada, said in a press release.
“It’s important that people living with hemophilia A have access to treatment options that are safe, effective, and have the ability to support better control of bleeding episodes and improve overall health outcomes,” he added.
Hemophilia A is a hereditary bleeding disorder that affects around 2,500 Canadians. It is caused by insufficient levels of factor VIII (FVIII), a protein that helps blood to clot. Hemophilia A can cause external and internal bleeding episodes, leading to severe complications.
Zonovate and Esperoct provide a man-made version of FVIII to help people with hemophilia A form blood clots and prevent bleeds.
Approved in 2014 by Health Canada, Zonovate has been available in Quebec since 2018. Zonovate is approved for use in children and adults as a prophylactic, or preventive, treatment given every two to three days to prevent or reduce bleeding episodes, or as an on-demand therapy to treat and control bleeds.
Esperoct contains a longer-acting version of a man-made form of FVIII. It was developed by adding a polyethylene glycol (PEG) molecule to Zonovate using site-specific glycoPEGylation technology.
Esperoct, approved by Health Canada in 2019, also helps people with hemophilia A manage bleeding episodes. It is indicated for use in adults and children as a prophylaxis, given every three to four days to individuals 12 years and older, or twice weekly to children younger than 12, to prevent or reduce bleeds. It may also be used as an on-demand therapy to stop bleeding episodes.
The therapy’s approval was based on data from the Pathfinder clinical trial program, which demonstrated the medication was well-tolerated with minimal side effects. The most common side effects reported were itching, skin redness, rash, and injection site reactions.
Both Zonovate and Esperoct are also indicated to prevent excessive bleeding during surgery.