Novo Nordisk has nominated semaglutide for inclusion in the FDA’s Demonstrable Difficulties for Compounding list, which includes drugs that are too complicated to produce and could pose substantial safety risks to patients if manufactured incorrectly.
Novo Nordisk is asking the FDA to stop compounding pharmacies from making altered versions of its blockbuster obesity treatment semaglutide, citing the “demonstrable difficulty” of safely producing the drug.
In filings, which the agency posted on its website on Tuesday, Novo nominated semaglutide for inclusion in the FDA’s Demonstrable Difficulties for Compounding (DDC) list, which identifies drugs that are too complicated to produce and could pose substantial safety risks to patients if manufactured incorrectly. Because of these risks, compounders are not allowed to produce drugs on the list regardless of supply constraints.
Novo argued that its semaglutide formulations are complex and approved drug products containing the therapeutic peptide possess “unique characteristics and properties that are challenging to reproduce using a synthetically produced peptide,” particularly since the Danish drugmaker produces its semaglutide using yeast systems with recombinant DNA technology.
The pharma pointed out that synthetic and compounded versions of semaglutide “have different impurity profiles and different physical and chemical stabilities” compared with the FDA-approved versions of the drug. Compounded semaglutide also lacks clinical testing and has resulted in calls to poison control centers, while also demonstrating problematic immunogenicity profiles, according to Novo.
“We have not identified any actual or potential benefit that would outweigh the risks presented by compounded semaglutide products,” Novo wrote in its filing.
Aside from adding semaglutide to the FDA’s DDC list, the company is also asking the regulator to convene its Pharmacy Compounding Advisory Committee and Drug Safety and Risk Management Advisory Committee to discuss the matter.
Semaglutide—marketed as Ozempic for type 2 diabetes and as Wegovy for chronic weight management—is a GLP-1 receptor agonist that promotes the secretion of insulin from the pancreas and helps suppress appetite.
Novo has struggled to maintain a semaglutide supply that could keep pace with the market’s demand. Last month, the pharma announced that shortages for the lower doses of Ozempic could last into the fourth quarter of this year. The FDA has also monitored the semaglutide shortage, with its website reflecting the limited availability of the lowest dose of Wegovy.
Compounders have tried to take advantage of semaglutide’s limited availability by providing altered versions of the drug. Novo has been pushing back, however, filing lawsuits against wellness clinics and medical spas in June 2023 and winning a permanent injunction ruling in February 2024.
Obesity rival Eli Lilly has also taken a strong stance against compounders. The pharma on Monday sued three retailers for selling remixed versions of its weight loss drug tirzepatide, as the FDA mulls putting the incretin therapy back on its shortage list.
