Boxes of Ozempic and Wegovy, manufactured by Novo Nordisk, can be found in pharmacies.
Holly Adams | Reuters
Novo Nordisk Tuesday asked the U.S. Food and Drug Administration Prevent compounding pharmacies Manufacturers of unapproved and often cheaper versions of the popular weight-loss injection Wegovy and diabetes treatment Ozempic argue the drugs are too complex for these manufacturers to produce safely.
The FDA still has to make a final decision on whether to ban the combined form of semaglutide, the active ingredient in Ozempic and Wegovy. The agency said in a statement that it was reviewing the petition and would respond directly to Novo Nordisk.
The move is the latest attempt by Novo Nordisk to crack down on potentially harmful generic versions of semaglutide, which filed 50 lawsuits against clinics, compounding pharmacies and other manufacturers last year. Meanwhile, the Danish drugmaker is trying to increase supplies of semaglutide to meet unprecedented demand in the U.S.
As the U.S. experiences intermittent shortages of the brand-name drug, patients are turning to semaglutide, which costs up to $1,000 a month before insurance and other rebates. Many health plans do not cover semaglutide for its weight-loss benefits, making the combined version a more affordable alternative.
Compounded drugs are customized alternatives to brand-name drugs designed to meet the needs of specific patients. When there is a shortage of a brand-name drug, the compounding pharmacy can prepare copies of the drug if it meets FDA requirements.
Semaglutide, the active ingredient in Wegovy and Ozempic, has been in intermittent shortages for the past two years. According to the FDA, the lowest dose of Wegovy is currently in short supply, but that drug and all other doses of Ozempic are available. FDA Drug Shortage Database.
But Novo Nordisk nominated semaglutide to the FDA late Tuesday List of “demonstrable compound difficulties”, These include complex drugs that are not allowed to be compounded even during shortages because they could pose safety risks.
“Semaglutide products fit this description due to their inherent complexity and the potential hazards of attempting to synthesize them,” Novo Nordisk said in a statement.
The Danish drugmaker cited several risks with combined semaglutide, including unknown impurities, incorrect dosage strengths and cases where the combined product does not contain semaglutide at all.
“The safe synthesis of these drugs is inherently complex and the risks they pose to patient safety far outweigh any benefits,” Novo Nordisk said in a statement. “The purpose of this nomination is to ensure that patients Only accept FDA-approved, safe and effective semaglutide products.”
FDA has warned before Regarding the risks of using compounded versions of so-called GLP-1, such as semaglutide. This refers to a popular class of drugs that mimic hormones produced in the gut to suppress a person’s appetite and regulate blood sugar.
本月早些時候，FDA 表示，索馬魯肽和類似藥物的複合版本可能對患者有風險，因為它們未經批准，這意味著該機構在投放市場之前不會審查其安全性、有效性和quality.
The FDA also stated in August that report received Patients who have overdosed on semaglutide due to an error (e.g., the patient self-administered an incorrect dose of treatment).
Both Wegovy and Ozempic are protected by patents in the United States and abroad, and Novo Nordisk and its competitors Eli Lilly and Company Does not provide the active ingredients in its medicines to outside parties. The companies say this raises questions about the products some manufacturers sell and market to consumers.
Tirzepatide is the active ingredient in Eli Lilly’s weight-loss injectable Zepbound and diabetes treatment Mounjaro.
Like Novo Nordisk, Eli Lilly has sued several weight loss clinics, medical spas and compounding pharmacies across the United States in the past year.
Notably, the FDA removed tilsiparatide from its shortage list in early October after more than a year, although some pharmacies said they were still working to stock branded versions of the drug. A trade group representing some composites manufacturers sued the FDA, which said it would reconsider its decision to remove tilsiparatide from the shortage list.
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