Novo Nordisk’s Hemophilia Hopeful Hits FDA Roadblock, Company Cuts Wegovy Supply
BIOMARKER
1. The FDA has rejected Novo Nordisk's application for concizumab, a drug for prophylactic treatment of hemophilia A and B.
2. The regulator has requested additional information regarding the manufacturing process and patient monitoring and dosing system.
3. Concizumab, designed to be administered subcutaneously, is a monoclonal antibody that targets the tissue factor pathway inhibitor (TFPI) protein to promote hemostasis.
4. In 2020, Novo paused three concizumab trials due to non-fatal thrombotic events in three patients.
5. The company resumed Phase III studies of concizumab later that year after finding a new path forward for the drug.
6. Positive Phase III data from 2022 showed that concizumab could reduce spontaneous and traumatic bleeds by 86%.
7. The hemophilia market is currently dominated by Roche's Hemlibra, which garnered $4.3 billion in revenue in 2022.
8. Novo also announced a temporary reduction in the supply of its obesity drug Wegovy (semaglutide) due to production problems at a contract manufacturing site in 2022.
9. Wegovy, approved in 2021, is a GLP-1 receptor agonist for weight control in obese patients.
10. Despite scaling production capacity, the supply of lower Wegovy dose strengths in the U.S. will be temporarily reduced, although production is reportedly "running well."