Drugmaker Novo Nordisk is taking motion to curb the massively popular compounded semaglutide industry, which offers 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 filing posted by the agency on Tuesday, attorneys for Novo Nordisk motive 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 intention 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 advised WIRED by way of e-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 business—and for the doubtless thousands and thousands of individuals at present taking compounded GLP-1 medication.
Injectable GLP-1 medication together with semaglutide and tirzepatide have been in scarcity since 2022 due to their huge popularity. 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 blended in-house and are presupposed to include the identical lively substances as the unique drug.
Telehealth suppliers have capitalized on the GLP-1 drug scarcity, providing sufferers compounded variations by way of quick virtual appointments. The observe has created rigidity with the pharmaceutical corporations that make the brand-name medication, for the reason that compounded variations are offered at a lot decrease costs. Ozempic and Wegovy can price 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 usually are not topic to FDA approval earlier than hitting the market. Which means that the FDA can’t vouch for the security, effectiveness, or high quality of compounded medication earlier than they’re offered to sufferers. The FDA has obtained multiple reports of adverse side effects, together with hospitalization, associated to attainable dosing errors related to compounded semaglutide merchandise.
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