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Wednesday, 6 November, 2024
HomeNews UpdateNovo seeks FDA ban on compounded Ozempic

Novo seeks FDA ban on compounded Ozempic

Novo Nordisk has asked the US Food and Drug Administration (FDA) to prevent compounding pharmacies from manufacturing their own versions of the company’s weight loss drug Wegovy and diabetes treatment Ozempic, arguing the drugs are too complex for the pharmacies to make safely.

However, it has been accused of being solely concerned with profits, and told to remedy its shortage of supply instead.

Compounded anti-obesity drugs are sold at vastly lower prices than the branded versions and can give patients access to drugs that are in shortage, reports The Hill.

Ozempic and Wegovy cost about $1 000 per month without discounts, and semaglutide, the active ingredient in both, has been in shortage for more than two years.

But the drug company wants the FDA to add semaglutide to a list of “complex medications” that compounders are not allowed to make, regardless of shortages, pointing to potential safety risks.

“These drugs are inherently complex to compound safely, and the risks they pose to patient safety far outweigh any benefits,” Novo Nordisk said in a statement.

The FDA has not yet made a final decision.

Novo Nordisk said its request “is a significant step towards keeping people safe from unapproved and potentially harmful versions of knock-off ‘semaglutide’ drugs, and that the company wants to ensure patients receive only FDA-approved, safe and effective semaglutide products”.

It cited several risks with compounded versions of semaglutide, including unknown impurities, incorrect dosage strengths and instances where a compounded product contained no semaglutide at all.

The Danish company’s request comes as it boosts efforts to increase supply in the US in response to escalating demand, while pushing for a crackdown on clinics, compounding pharmacies and other manufacturers selling what it alleges are unsafe knockoff versions of semaglutide.

Compounded versions of semaglutide are not approved by the FDA, and the agency earlier this month said they can pose a risk to patients.

However, hitting back, the Alliance for Pharmacy Compounding noted that adverse events reported by patients taking compounded versions of the drug “are remarkably similar to those reported by patients taking the FDA-approved version”.

In a statement, the group’s CEO Scott Brunner asked why, if Novo Nordisk were so concerned about patient safety, it took the company two and a half years into the shortage to nominate semaglutide to FDA’s complex medication lists.

“This looks more like desperation and an attempt by Novo to protect its revenue stream than a serious scientific argument,” Brunner said.

“Novo’s ridiculous claims to the contrary… compounding pharmacies are dispensing compounded versions of those life-enhancing drugs to hundreds of thousands of patients. I get that Novo doesn’t like it, but the answer is not to restrict patient access … it’s for [Novo] to fix its supply chain,” he added.

 

The Hill article – Novo Nordisk asks FDA to block compounding pharmacies from making Ozempic copycats (Open access)

 

See more from MedicalBrief archives:

 

FDA issues dosage warning for semaglutide compound

 

Fake Ozempic sends users to hospitals

 

WHO warning on fake diabetes, weight loss drugs

 

 

 

 

 

 

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