Update on Novo Nordisk manufacturing deviation for NovoSeven©, resulting in shortages for NovoEight© and Esperoct©

Mid-June 2024, the European Haemophilia Consortium (EHC), National Bleeding Disorder Foundation (NBDF) and 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. This manufacturing deviation resulted in some NovoSeven (1 and 2 mg) vials being potentially underfilled in informed countries and resulted in shortages of NovoSeven, NovoEight and Esperoct.

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 (NMOs) and will keep informing them of any relevant information provided by Novo Nordisk. Haemophilia treatment centres (HTCs) 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 on the timeline to go back to normal for all three drugs.

Read the full statement

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