The US Food and Drug Administration (FDA) has officially declared an end to the supply squeeze on Novo Nordisk’s semaglutide, a diabetes and obesity medication that had been in high demand due to a shortage. The resolution marks the end of widespread GLP-1 compounding, a practice where pharmacies manufacture close approximations of branded drugs when they are in shortage.
The FDA reclassified the semaglutide shortage as “resolved” on its online drug shortage database, indicating that all doses of Wegovy for obesity and Ozempic for type 2 diabetes are now available. Novo Nordisk is producing semaglutide continuously to meet demand, with production facilities running 24/7.
The company has warned that making or selling compounded Ozempic and Wegovy will be illegal under compounding laws, except in rare cases. Compounded drugs typically come at a fraction of the cost of branded counterparts but are not subject to the same safety standards.
Telehealth companies like Hims & Hers have raked in enormous revenues by filling the supply gap for semaglutide and Eli Lilly’s tirzepatide during the shortage. However, Novo Nordisk has repeatedly pushed back against the practice, arguing that knockoff GLP-1s are not safe to use.
The resolution of the semaglutide shortage may spell the end of unfettered market access for compounded drugs, with analysts predicting that hundreds of thousands of patients will need to transition from compounded versions to FDA-approved versions.
Source: https://www.fiercepharma.com/pharma/novo-nordisks-semaglutide-shortage-officially-concludes-us-spelling-major-threat-weight-loss