Drugmaker Novo Nordisk is taking motion to curb the massively common compounded semaglutide trade, which gives copies of its blockbuster weight-loss medication Ozempic and Wegovy to sufferers—typically for a lot decrease costs.
The Danish pharmaceutical firm is lobbying the US Meals and Drug Administration so as to add semaglutide to the company’s Demonstrable Difficulties for Compounding (DDC) lists, which might block compounding pharmacies from producing dupes of the drug. In a submitting posted by the company on Tuesday, legal professionals for Novo Nordisk purpose that semaglutide belongs on these lists “as a result of complexities related to their formulations,” amongst different causes.
“These medication are inherently advanced to compound safely, and the dangers they pose to affected person security far outweigh any advantages. Novo Nordisk’s purpose with this nomination is to make sure that sufferers obtain solely FDA-approved, protected, and efficient semaglutide product,” says Novo Nordisk director of media relations Jamie Bennett.
FDA press officer Amanda Hils informed WIRED through electronic mail that the company “is reviewing the petition and can reply on to the petitioner.”
If granted, the designation would have seismic implications for the compounding trade—and for the probably tens of millions of individuals presently taking compounded GLP-1 medication.
Injectable GLP-1 medication together with semaglutide and tirzepatide have been in scarcity since 2022 due to their large reputation. Within the US, when the FDA declares {that a} drug is in scarcity, sure licensed pharmacies are permitted to make “compounded” variations of the remedy, that are combined in-house and are speculated to comprise the identical energetic components as the unique drug.
Telehealth suppliers have capitalized on the GLP-1 drug scarcity, providing sufferers compounded variations through fast digital appointments. The apply has created stress with the pharmaceutical firms that make the brand-name medication, for the reason that compounded variations are offered at a lot decrease costs. Ozempic and Wegovy can value round $1,000 a month with out insurance coverage, whereas compounded semaglutide is marketed for as little as $100 a month on-line.
In contrast to generic drugs, that are manufactured after drug patents expire, compounded drugs should not topic to FDA approval earlier than hitting the market. Which means that the FDA can not vouch for the protection, effectiveness, or high quality of compounded medication earlier than they’re offered to sufferers. The FDA has acquired a number of studies of adversarial uncomfortable side effects, together with hospitalization, associated to potential dosing errors related to compounded semaglutide merchandise.
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