Drugmaker Novo Nordisk is taking motion to curb the vastly in style compounded semaglutide business, which supplies copies of its blockbuster weight-loss medicine Ozempic and Wegovy to sufferers—frequently for a lot decrease costs.
The Danish pharmaceutical corporate is lobbying the USA Meals and Drug Management so as to add semaglutide to the company’s Demonstrable Difficulties for Compounding (DDC) lists, which might block compounding pharmacies from generating dupes of the drug. In a submitting posted by way of the company on Tuesday, attorneys for Novo Nordisk explanation why that semaglutide belongs on those lists “because of the complexities related to their formulations,” amongst different causes.
“Those medicine are inherently complicated to compound safely, and the hazards they pose to affected person protection a ways outweigh any advantages. Novo Nordisk’s purpose with this nomination is to make sure that sufferers obtain most effective FDA-approved, protected, and efficient semaglutide product,” says Novo Nordisk director of media members of the family Jamie Bennett.
FDA press officer Amanda Hils instructed WIRED by the use of e-mail that the company “is reviewing the petition and can reply at once to the petitioner.”
If granted, the designation would have seismic implications for the compounding business—and for the most probably hundreds of thousands of folks these days taking compounded GLP-1 medicine.
Injectable GLP-1 medicine together with semaglutide and tirzepatide were in scarcity since 2022 as a result of their massive recognition. In the USA, when the FDA broadcasts {that a} drug is in scarcity, sure authorized pharmacies are authorized to make “compounded” variations of the drugs, which can be blended in-house and are meant to include the similar energetic substances as the unique drug.
Telehealth suppliers have capitalized at the GLP-1 drug scarcity, providing sufferers compounded variations by the use of fast digital appointments. The apply has created stress with the pharmaceutical corporations that make the brand-name medicine, 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, whilst compounded semaglutide is marketed for as little as $100 a month on-line.
Not like generic drugs, which can be manufactured after drug patents expire, compounded drugs don’t seem to be topic to FDA approval ahead of hitting the marketplace. Which means that the FDA can’t vouch for the protection, effectiveness, or high quality of compounded medicine ahead of they’re offered to sufferers. The FDA has won more than one studies of difficult negative effects, together with hospitalization, associated with imaginable dosing mistakes related to compounded semaglutide merchandise.
