FDA Removes Wegovy from Shortage List as Novo Nordisk Resolves Supply Issues
The FDA has removed Novo Nordisk's weight-loss drug, Wegovy, from its drug shortage list, indicating that all dose strengths are now available, as Novo Nordisk's efforts to increase production meet the high demand for GLP-1 therapies like Wegovy and Ozempic.
The FDA's action comes shortly after removing Eli Lilly's tirzepatide-based drugs, Mounjaro and Zepbound, from the shortage list.
The following article originally appeared in Fierce Pharma.
Less than a month after the FDA removed Eli Lilly’s tirzepatide from its shortage list, a similar situation is playing out for Novo Nordisk’s rival GLP-1 semaglutide, potentially signaling the end of a diabetes and obesity med shortage that has spanned multiple years.
The FDA this week revised its shortage list to note that the 0.25 mg starter dose of Novo’s semaglutide-based obesity med Wegovy is now available in the U.S. The 0.25 mg presentation of the popular metabolic medicine was the last dose of either Wegovy or its type 2 diabetes sibling Ozempic to be listed as in shortage by the FDA.
Novo Nordisk is now regularly shipping all doses of Ozempic and Wegovy to wholesalers around the country, a company spokesperson said over email. The supply improvement is a testament to the fact that Novo's “intentional approach to gradually increase supply into the U.S. market is working,” the spokesperson added.
Notably, while all Ozempic and Wegovy doses are now listed as available, the FDA has not formally determined that the situation is resolved, as was the case with Eli Lilly's tirzepatide in early October.
Novo Nordisk has been on a yearslong push to bolster manufacturing capacity for its GLP-1 blockbusters after Ozempic and Wegovy garnered massive mainstream popularity thanks to their ability to help patients lose weight.
While Ozempic is indicated for the treatment of type 2 diabetes, the med experienced a surge in off-label use among patients seeking to curb their appetites and slim down.
Though Novo’s Wegovy, approved in 2021 to treat obesity specifically, provided an official avenue for obese and overweight patients seeking to manage their weight with medication, the drug quickly ran into shortage issues thanks to high demand and an unfortunate contract manufacturing hitch that put near-term supply into question toward the end of 2021.
Among Novo’s notable manufacturing investments, the company in June announced that it was throwing down $4.1 billion to build a second fill-finish plant at its massive campus in Clayton, North Carolina.
The move forms part of Novo’s planned $6.8 billion manufacturing investment this year, up from an outlay of $3.9 billion in 2023.
Elsewhere, Novo Holdings, which acts as a holding company for the drugmaker, revealed plans to purchase contract manufacturing giant Catalent for $16.5 billion in early February. As part of the deal, Novo Nordisk is slated to purchase three Catalent fill-finish sites from Novo Holdings for $11 billion once the transaction closes.
Novo currently splits the GLP-1 market for diabetes and obesity with its rival Eli Lilly, which has also run into supply constraints with its counterpart products Mounjaro and Zepbound.
Earlier this month, the FDA removed Lilly’s meds from its shortage list, putting an end to a 22-month supply squeeze.
While undoubtedly a win for Lilly, the move drew the ire of compounding pharmacies, which have been filling the gaps when it comes to supply of Novo and Lilly’s GLP-1s—and raking in profits along the way.
In turn, compounding industry group the Outsourcing Facilities Association (OFA) sued the FDA, calling the decision to remove Mounjaro and Zepbound from the shortage list a “reckless and arbitrary decision.”
Less than a week after the complaint was filed, the FDA said it would allow compounders to continue manufacturing and selling their versions of Lilly’s drugs while the agency reviews whether there is a shortage of the active ingredient used to make both products.
Novo has also sparred with compounders and counterfeiters and just last week asked the FDA to add semaglutide to its Demonstrable Difficulties for Compounding (DDC) lists.
“Novo Nordisk’s aim with this nomination is to ensure that patients receive only FDA-approved, safe, and effective semaglutide products,” a company spokesperson said at the time.
While all Ozempic and Wegovy doses are now listed as available, Novo’s spokesperson cautioned in an email Wednesday that “patients may not always be able to immediately fill their prescription at a particular pharmacy,” noting that supply variability at individual outlets is par for the course—regardless of whether a drug is in shortage.
Additionally, Novo isn’t out of the woods yet when it comes to GLP-1 supplies overseas.
Back in early September, the European Medicines Agency (EMA) cautioned that increased demand and capacity constraints at some manufacturing sites had disrupted supply and even led to “out-of-stock situations” for Ozempic. Those hurdles have spurred intermittent shortages for all strengths of Ozempic, with the situation expected to extend into 2024’s fourth quarter, the EMA said at the time.
Editor's note: This story was updated at 4:20 p.m. ET on Friday, Nov. 1, 2024, to clarify that the FDA has not formally listed the semaglutide shortage as resolved.
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