Mid-June 2024, the European Haemophilia Consortium (EHC), the National Bleeding Disorder Foundation (NBDF) and the World Federation of Hemophilia (WFH) were made aware of a manufacturing deviation in the production lines of several products for the treatment of haemophilia and other coagulopathies manufactured by Novo Nordisk in Denmark, mainly NovoSeven (1 and 2 mg vials), NovoEight, and Esperoct (all vials). This manufacturing deviation resulted in some vials being underfilled.
The potential supply problems of NovoEight (a standard half-life FVIII concentrate) and Esperoct (an extended half-life FVIII concentrate), although significant, can be mitigated using several alternative standard half-life and/or extended half-life clotting factor concentrates. The EHC, NBDF, and WFH expect Novo Nordisk to provide timely updates on potential shortages and the timeline of going back to normal.
The manufacturing issue has not caused serious supply problems for the time being, but its full impact might manifest later, likely by the end of 2024.
The EHC and WFH have communicated with their national member organisations and will keep informing them of any relevant information provided by Novo Nordisk. Haemophilia treatment centres and regulators around the world are aware of the situation.
The EHC, NBDF, and WFH have stayed in touch with Novo Nordisk and are expecting more details on the stocks under quarantine, the number of vials that could potentially be shipped and used and the timeline to go back to normal for all three drugs.
Jim is aged 66 and has Haemophilia A with a high titer inhibitor which he developed at age 14.
Maria Elisa Mancuso (MD, PhD) is a Haematologist and works as a Senior Haematology Consultant at the Center for Thrombosis and Haemorrhagic Diseases of IRCCS Humanitas Research Hospital in Rozzano, Milan, Italy. She is Adjunct Clinical Professor at Humanitas University. She obtained a post-degree in Clinical and Experimental Haematology and a PhD in Clinical Methodology. She is involved in clinical research and has published several original articles in peer-reviewed journals a The Lancet, Blood, Journal of Thrombosis and Haemostasis, Haematologica, Thrombosis and Haemostasis, British Journal of Haematology and Haemophilia. She is reviewer for several peer-reviewed journals and member of the Editorial Board of JTH. She is a member of several scientific societies (ISTH, WFH, ASH, EAHAD, SISET, AICE) and was a medical member of the Inhibitor Working Group of the European Hemophilia Consortium. She is co-chair of the ADVANCE Study Group. She has acted also as co-chair of the Scientific and Standardization Subcommittee of ISTH on FVIII, FIX and rare bleeding disorders. She has been involved as principal and co-investigator in several clinical trials, and she takes care of both children and adults with hemophilia and other congenital bleeding disorders with a specific scientific interest in novel therapies, prophylaxis, inhibitors, and chronic hepatitis C.
As a patient with factor II deficiency, the diagnostic and treatment of rare bleeding disorders is a matter dear to my heart. My motivation to participate in the work of the ERIN committee is to improve both diagnostic and treatment for patients with rare bleeding disorders across Europe.
Economist and financial expert by profession, executive coach and trainer by passion and haemophilia advocate by every drop of my blood through my son (who has severe haemophilia A with inhibitors). Bringing a good decade of practical experience from the corporate insurance world, laser focus, growth mindset and resilience from my own experience, offering you anything I can just do, in hope that together we can make life more fulfilled for those impacted by bleeding disorders.
Amy Owen-Wyard is a Registered Mental Health Nurse. With experience working with children, young people, their families and adults with severe and enduring mental health conditions. Amy was also involved in a service improvement to provide a holistic care approach for those in general hospitals to support both their mental and physical health, whilst sharing her expertise and knowledge in mental health with the wider multidisciplinary team.
