Novo Nordisk (NYSE:NVO) continues to face supply shortages for its Wegovy (semaglutide) pens, which are FDA approved for weight management.
Against that backdrop, a growing number of companies have begun selling compounded versions of the drug.
Drug compounding involves “combining, mixing, or altering ingredients to create a medication tailored to the needs of an individual patient,” according to the FDA. Compounding drugs are not FDA approved, nor does the agency validate their safety, effectiveness or quality.
Novo Nordisk notes on its website that it has “become aware of an increasing trend in compounding pharmacies purporting to have availability of Wegovy or semaglutide.” The company adds that it “does not sell Wegovy (or its active ingredient, semaglutide) for the purposes of compounding with other products.” Novo Nordisk is the only company with FDA approval related to Wegovy, which is offered as a prescription-based single-use pen.
A number of companies have responded by selling compounded formulations of the drug online, raising intellectual property questions.
One company, Compounding Pharmacy of America, notes that it “offers our advanced semaglutide product in the form of a weekly subcutaneous injection.” This version of the drug is mixed with L-carnitine.
The Ohio-based aesthetic medical center Cru Clinic promotes a compounded version of the drug to residents of the company’s home state.
Other purveyors of compounded semaglutide, such as Galleria Medical Pharmacy, combine the drug with vitamin B-12.
The Alliance for Pharmacy Compounding notes on its website that it “cannot compound a copy of a commercially available medication,” but added, “if a patient needed semaglutide in a nasal spray, for example, it would be legal to compound it.”
While Wegovy costs about $1,600 per month before insurance, compounders offer prices substantially lower. Cru Clinic, for instance, provides a monthly supply of semaglutide for $300.
Many physicians have raised concerns about the trend. Dr. Fatima Cody Stanford, an obesity doctor at Massachusetts General Hospital in Boston, told MedPage Today: “My assumption would be that they’re making an agent that’s close,” but that “I can’t chance anything with my patients. I need to see the data to support the use.”
Filed Under: Metabolic disease/endicrinology
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