Alhemo® injection is FDA-approved as a once-daily prophylactic treatment to prevent or reduce the frequency of bleeding episodes in adults and children aged 12 years and older with hemophilia A or B with inhibitors.
Data from the pivotal Phase 3 trial (explorer7) confirm that Alhemo® is safe and effective for daily prevention of bleeds in adults and pediatric patients aged 12 years and older with hemophilia A or B with inhibitors. Results from the pivotal trial demonstrated an 86% reduction in treated spontaneous and traumatic bleeds in Alhemo® prophylaxis patients compared to those not on prophylaxis. It is the first subcutaneous injection approved for this patient population.
Hemophilia is a rare blood disorder in which the body cannot form a blood clot. This condition impacts nearly 32,000 US residents and over 800,000 worldwide. The design with Alhemo® is to block a protein in the body called tissue factor pathway inhibitor (TFPI) that prevents blood clotting. Alhemo® prevents bleeding by blocking TFPI and thereby enhances thrombin production when other plasma clotting factors are deficient or absent in the presence of an inhibitor. Alhemo® increases factor Xa (FXa) production in the initiation coagulation phase and therefore enhances thrombin generation and clot formation in patients with hemophilia A or B with inhibitors.
Alhemo® (concizumab mtci) injections available in doses of 60 mg, 150 mg, and 300 mg, are indicated for routine prophylaxis to prevent or reduce the frequency of bleeding episodes in adults and children aged 12 years or older with hemophilia A with factor VIII inhibitors or hemophilia B with factor IX inhibitors.
In the US, Alhemo® is approved as a once-daily prophylaxis to prevent or reduce bleeding episodes in children aged 12 years and older with hemophilia A or B and inhibitors.
The approval of Alhemo® is a remarkable achievement for prophylactic hemophilia treatment in patients aged 12 years and older who in some instances have few treatment options, says Anna Windle SVP of Clinical Development, Novo Nordisk. “Alhemo® is the first treatment of its kind for this population and is a leap forward in addressing the needs patients with hemophilia with inhibitors have not been met so far,” said Sophie Clements, Senior Vice President and Head of Digital and Rare Diseases at Novo Nordisk.
Injection site reactions and urticaria were reported in more than 5% of patients in the explorer7 study. In two patients, renal infarction and hypersensitivity reactions were considered serious adverse reactions. Alhemo® should not be used if you are allergic to concizumab-mtci or any of the ingredients in the Alhemo®.
Before using Alhemo®, inform your healthcare professional (HCP) about your medical conditions including any planned surgeries. Your HCP may temporarily discontinue Alhemo® treatment before surgery and advise on when to resume it afterward. While Alhemo® has not been reported to harm an unborn child, consult your HCP if you are planning to conceive. If you are breastfeeding or plan to breastfeed, discuss with your HCP the best approach to feeding your baby while on Alhemo®.
Reference: Novo Nordisk USA. FDA approves Alhemo® injection as once-daily prophylactic treatment to prevent or reduce the frequency of bleeding episodes for adults and children 12 years of age and older with hemophilia A or B with inhibitors. Published December 21, 2024. https://www.novonordisk-us.com/media/news-archive/news-details.html?id=915084
