Ozempic and Wegovy boxes made by Novo Nordisk appear in a drugstore.
Holly Adams | Reuters
Novo Nordisk On Tuesday, it asked the Food and Drug Administration to prevent compounding pharmacies from making unapproved and often cheaper versions of Wegovy's popular weight-loss and diabetes treatment shot Ozempic, arguing that the drugs are too complex for those manufacturers to make them safely.
The FDA has yet to make a final decision on whether to ban combination versions of semaglutide, the active ingredient in Ozempic and Wegovy. The agency said in a statement that it is reviewing the petition and will respond directly to Novo Nordisk.
The move is Novo Nordisk's latest attempt to crack down on potentially harmful versions of semaglutide after it filed 50 lawsuits against several clinics, compounding pharmacies and other manufacturers over the past year. This comes as the Danish pharmaceutical company tries to increase the supply of semaglutide to meet unprecedented demand in the United States.
Patients have turned to combination versions of semaglutide amid intermittent U.S. shortages of the brand-name drugs, which carry hefty prices of up to $1,000 a month before insurance and other rebates. Many health plans do not cover the weight-loss drug semaglutide, making combination versions a less expensive alternative.
Compounded medications are customized alternatives to brand-name medications designed to meet the needs of a specific patient. When there is a shortage of brand-name drugs, compounding pharmacies can prepare versions of the drug if they meet FDA requirements.
The active ingredient in Wegovy and Ozempic, semaglutide, has been in intermittent shortages over the past two years. The lowest dose of Wegovy is not currently available, but all other doses of the drug and Ozempic are listed as available, according to the FDA's drug shortage database.
But Novo Nordisk late Tuesday nominated semaglutide to the FDA's “demonstrably difficult to formulate” lists, which include complex drugs that formulators are not allowed to manufacture, even during a shortage, because they may pose safety risks.
“Semaglutide products fit this description due to their inherent complexity and the potential risks associated with attempting to formulate them,” Novo Nordisk said in a statement.
The Danish pharmaceutical company cited several risks related to combination versions of semaglutide, including unknown impurities, incorrect dosage strengths and cases where the combination product does not contain semaglutide at all.
“These drugs are too complex to formulate safely, and the risks they pose to patient safety far outweigh any benefits,” Novo Nordisk said in a statement. The company said its “goal with this nomination is to ensure that patients receive only safe and effective FDA-approved semaglutide products.”
The FDA has previously warned of the risks of using compounded versions of so-called GLP-1s such as semaglutide. This refers to a class of medications that mimic hormones produced in the intestines to reduce a person's appetite and regulate blood sugar.
Earlier this month, the FDA said combination versions of semaglutide and similar drugs could be dangerous to patients because they are unapproved, meaning the agency does not review their safety, effectiveness and quality before putting them on the market.
The FDA also said in August that it had received reports of patients taking overdoses of the compound semaglutide due to errors such as patients giving themselves incorrect amounts of the treatment.
Wegovy and Ozempic are both subject to patent protection in the United States and abroad, as is Novo Nordisk and its competitor Eli Lilly It does not provide the active ingredients in its medications to outside groups. The companies say this raises questions about what some manufacturers are selling and marketing to consumers.
Tirzepatide is the active ingredient in Eli Lilly's Zepbound weight loss injection and Mounjaro diabetes treatment.
Like Novo Nordisk, Eli Lilly has sued several weight loss clinics, medical spas and compounding pharmacies across the United States over the past year.
Notably, the US Food and Drug Administration removed tirzepatide from its shortage list earlier in October after more than a year, although some pharmacies say they are still struggling to stock branded versions of the drug. A trade group representing some of the compounds has filed a lawsuit against the FDA, prompting the agency to say it will reconsider its decision to remove tirzepatide from its deficiency list.
