Drugmaker Novo Nordisk is taking motion to curb the massively widespread compounded semaglutide business, which gives copies of its blockbuster weight-loss medicine Ozempic and Wegovy to sufferers—usually 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 motive that semaglutide belongs on these lists “because of the complexities related to their formulations,” amongst different causes.
“These medicine are inherently complicated to compound safely, and the dangers they pose to affected person security far outweigh any advantages. Novo Nordisk’s goal 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 seemingly hundreds of thousands of individuals presently taking compounded GLP-1 medicine.
Injectable GLP-1 medicine together with semaglutide and tirzepatide have been in scarcity since 2022 due to their large recognition. 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 purported to comprise 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 fast digital appointments. The follow has created rigidity with the pharmaceutical firms that make the brand-name medicine, for the reason that compounded variations are bought 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.
Not like generic drugs, that are manufactured after drug patents expire, compounded drugs should not topic to FDA approval earlier than hitting the market. Because of this the FDA can’t vouch for the security, effectiveness, or high quality of compounded medicine earlier than they’re bought to sufferers. The FDA has obtained a number of experiences of opposed unwanted side effects, together with hospitalization, associated to potential dosing errors related to compounded semaglutide merchandise.
