Health Canada approves Alhemo™ (concizumab injection) for the treatment of patients living with hemophilia A with FVIII inhibitors

MISSISSAUGA, ON, Aug. 9, 2023 /CNW/ – Health Canada has approved a new indication for Alhemo™ (concizumab injection) for the treatment of Canadian adolescent and adult patients with hemophilia A (congenital factor VIII [FVIII] deficiency) who have FVIII inhibitors.¹ Alhemo™ was first approved by Health Canada in March 2023 for the treatment of patients who have FIX inhibitors and require routine prophylaxis to prevent or reduce the frequency of bleeding episodes.¹ 

Hemophilia A is a hereditary bleeding disorder caused by insufficient levels of a blood protein called factor VIII.^2,3 This prevents blood from clotting normally.² In Canada, hemophilia A impacts an estimated 1 in 10,000 people, or about 2,500 Canadians.² 

In mild cases, people living with hemophilia A may experience prolonged bleeding episodes after surgery, dental procedures or trauma. In more severe cases, people may experience prolonged bleeding from minor wounds, painful swollen bruises, and spontaneous bleeding into vital organs as well as joints and muscles.³ While there is no cure for hemophilia, with proper treatment and care affected individuals can live full and productive lives.³

“We are pleased to expand the Alhemo™ indication to treat hemophilia A with factor VIII inhibitors,” says John Burrows, Vice President, Rare Disease, Novo Nordisk Canada Inc. “This represents significant progress for the rare disease community, and an additional option to support those living with hemophilia A with inhibitors. This new indication for Alhemo™ builds upon Novo Nordisk’s commitment to the hemophilia community and supports our goal of improving hemophilia care for patients across Canada.”

Alhemo™ is used to treat people living with hemophilia A or hemophilia B (which is caused by missing or dysfunctional proteins [factor VIII or factor IX, respectively] that prevent blood from clotting normally) and who have developed inhibitors against FVIII or FIX.¹ 

Alhemo™ contains an active substance concizumab, which belongs to a group of medicines called “monoclonal antibodies”.¹ The monoclonal antibody in Alhemo™ recognizes a protein (Tissue Factor Pathway Inhibitor (TFPI)) that prevents or downregulates clotting. By binding to this protein, Alhemo™ allows to improve clotting and stop bleeding in hemophilia patients with inhibitors.¹ Alhemo™ is the first approved ready-to-use subcutaneous prophylaxis treatment for people living with Hemophilia A or B with inhibitors.

About
Alhemo™

Alhemo™ was approved by Health Canada on March 10, 2023, making Canada the first country in the world to receive approval.¹ Alhemo™ is indicated for the treatment of adolescent and adult patients (12 years of age or older) with hemophilia A (congenital factor VIII [FVIII] deficiency) who have FVIII inhibitors or hemophilia B (congenital factor IX [FIX] deficiency) who have FIX inhibitors and require routine prophylaxis to prevent or reduce the frequency of bleeding episodes.  

Alhemo™ is the first anti-TFPI (Tissue Factor Pathway Inhibitor) approved worldwide. Alhemo is the first approved subcutaneous (subQ) prophylaxis treatment for hemophilia B patients with FIX inhibitors, and an additional subQ prophylaxis treatment option for hemophilia A patients with FVIII inhibitors.

For more information on Alhemo™ including important safety information please visit NovoNordisk.ca or view the product monograph here.

About Novo Nordisk

Novo Nordisk is a leading global healthcare company, founded in 1923 and headquartered in Denmark. Our purpose is to drive change to defeat diabetes and other serious chronic diseases such as obesity and rare blood and endocrine disorders. We do so by pioneering scientific breakthroughs, expanding access to our medicines, and working to prevent and ultimately cure disease. Novo Nordisk employs about 54,400 people in 80 countries and markets its products in around 170 countries. For more information, visit novonordisk.com, Facebook, Twitter, LinkedIn and YouTube.

SOURCE Novo Nordisk Canada Inc.

For further information: Media: Amy Snow, 647-202-6367, [email protected]