Novo Nordisk on Tuesday called on the Food and Drug Administration to stop compounding pharmacies from making unapproved and often cheaper versions of its popular weight-loss shot Wegovy and diabetes drug Ozempic, arguing that the drugs are too complex for those manufacturers to produce safely could.
The FDA has yet to make a final decision on whether to ban compounded versions of semaglutide, the active ingredient in Ozempic and Wegovy. In a statement, the agency said it was reviewing the petition and would respond directly to Novo Nordisk.
The move is Novo Nordisk's latest attempt to crack down on potentially harmful copies of semaglutide, after the company filed 50 lawsuits last year against several clinics, compounding pharmacies and other manufacturers. The Danish drugmaker is trying to increase supply of semaglutide to meet unprecedented demand in the United States
Patients are turning to compounded versions of semaglutide amid intermittent U.S. shortages of the brand-name drugs, which come with high prices of $1,000 a month without insurance and other discounts. Many health insurance plans don't cover semaglutide for weight loss, making compounded versions a cheaper alternative.
Compounded medications are customized alternatives to brand-name medications tailored to the needs of a specific patient. When a brand-name drug is in short supply, pharmacies that manufacture drugs can make copies of the drug if they meet FDA requirements.
The active ingredient in Wegovy and Ozempic, semaglutide, has experienced temporary shortages over the past two years. The lowest dose of Wegovy is currently in short supply, 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 added semaglutide to the FDA's list of “demonstrated difficulties in compounding,” which includes complex drugs that compounders are not allowed to make, even amid shortages, because they could potentially pose safety risks.
“Semaglutide products fit this description due to their inherent complexity and the potential dangers associated with attempting to compound them,” Novo Nordisk said in a statement.
The Danish drugmaker cited several risks with compounded versions of semaglutide, including unknown impurities, incorrect dosage strengths and cases where a compounded product contained no semaglutide at all.
“It is inherently complex to produce these medicines 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 FDA-approved, safe and effective semaglutide products.”
The FDA has previously warned about the risks of using compounded versions of so-called GLP-1s like semaglutide. This refers to a powerful class of drugs that mimic hormones produced in the gut to suppress a person's appetite and regulate their blood sugar.
Earlier this month, the FDA said compounded versions of semaglutide and similar drugs could be risky for patients because they were not approved. This means the agency does not review their safety, effectiveness, and quality before they come to market.
The FDA also said in August that it had received reports of patients overdosing on the compounded semaglutide due to errors, such as patients giving themselves incorrect amounts of treatment.
Both Wegovy and Ozempic are under patent protection in the United States and abroad, as are Novo Nordisk and its rival Eli Lilly do not supply the active ingredients of their 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 weight loss shot Zepbound and diabetes treatment Mounjaro.
Like Novo Nordisk, Eli Lilly sued several weight loss clinics, medical spas and pharmacies in the US last year.
Notably, the FDA removed tirzepatide from its shortage list in early October after more than a year, although some pharmacies say they are still struggling to stock up on the brand-name versions of this drug. A trade group representing some compounders sued the FDA, and the agency announced it would reconsider its decision to remove tirzepatide from its shortage list.
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