Pictured: Novo Nordisk building in California/iStock, hapabapa
Thursday, Novo Nordisk filed legal complaints against three pharmacies in Florida and one in Tennessee for allegedly selling products that contain semaglutide, the active compound in the company’s best-selling weight-loss and diabetes drugs Ozempic, Wegovy and Rybelsus, Bloomberg reported.
Novo filed three separate lawsuits in Florida federal court, targeting three compounding pharmacies: WellHealth, TruLife Pharmacy and Brooksville Pharmaceuticals. A fourth lawsuit was filed in Tennessee against DCA Pharmacy. The Danish drugmaker is asking the courts to block these pharmacies from marketing their semaglutide-containing products and is seeking unspecified financial damages.
This latest round of lawsuits comes two weeks after Novo sent out a barrage of legal complaints against wellness and weight loss clinics, medical spas and other compounding pharmacies, also claiming that these businesses were selling products containing semaglutide.
Semaglutide is a peptide that mimics the GLP-1 hormone to active its counterpart receptor. In turn, this induces the pancreas to secrete an appropriate amount of insulin in response to a high blood sugar concentration. This mode of action allows semaglutide to promote weight-loss in overweight or obese individuals and help Type 2 diabetes patients control their glucose levels.
Semaglutide also moderates the production of glucose in the liver and the release of glucagon from the pancreas, leading to lower fasting and postprandial glucose levels.
Novo exclusively owns semaglutide and won its first FDA approval for the molecule in September 2019. The resulting drug product, sold under the brand name Rybelsus, is the first oral semaglutide formulation authorized. In January 2020, semaglutide was again approved to lower the likelihood of major adverse cardiovascular events in patients with Type 2 diabetes and is being marketed as Ozempic in this indication.
Semaglutide’s latest regulatory win came in June 2021 when it won the brand name Wegovy and became the first and only prescription weight-loss treatment. Wegovy is given alongside dietary, exercise and other lifestyle adjustments.
Novo’s legal offensive follows an FDA announcement in June 2023 warning consumers that compounded forms of semaglutide are being marketed despite having potentially harmful side effects.
Compounded drugs are medicines that have been altered or combined with other components, such as salts. The compounding process can substantially alter a product’s tolerability, efficacy and quality profiles and the regulator cannot assure consumers that these medicines are safe or will work as intended.
“Purchasing medicine online from unregulated, unlicensed sources can expose patients to potentially unsafe products that have not undergone appropriate evaluation or approval, or do not meet quality standards,” the FDA wrote in its announcement, adding that patients should only get their semaglutide products from licensed providers.
Tristan Manalac is an independent science writer based in metro Manila, Philippines. He can be reached at tristan@tristanmanalac.com or tristan.manalac@biospace.com.
