Wednesday’s update to the regulator’s drug shortage database is good news for Novo Nordisk, which has struggled to keep up with demand for the blockbuster GLP-1 drugs.
All doses of Novo Nordisk’s semaglutide—sold as Ozempic for type 2 diabetes and as Wegovy for obesity—are now available, according to a Wednesday update to the FDA’s drug shortages database.
Still, the regulator’s webpage continues to list semaglutide’s status as “currently in shortage.” It is unclear if compounders will need to stop producing and marketing their remixed versions of semaglutide due to Wednesday’s supply update—or if the FDA will enforce action against these pharmacies.
Earlier this month, the FDA announced that it was rethinking the shortage status of Eli Lilly’s tirzepatide brands Mounjaro and Zepbound—which the regulator had taken off its shortage list just days earlier—after a complaint from the Outsourcing Facilities Association (OFA). In its lawsuit, the trade group called the FDA “reckless” in declaring the end of the tirzepatide shortage, noting that the decision could “deprive patients of a vital treatment for type 2 and obesity.”
Currently, the FDA still officially considers the tirzepatide shortage to be “resolved,” according to its website. It remains to be seen whether the OFA will file a similar complaint for semaglutide.
Wednesday’s supply update comes after nearly a year of aggressive manufacturing investments from Novo. In November 2023, the pharma announced a $6 billion boost to its production capacity in Denmark, dedicated for a multi-product facility focused on active pharmaceutical ingredients. Novo in March 2024 also injected $556 million into its Chinese operation, following it up in June 2024 with a $4.1 billion commitment to its manufacturing footprint in North Carolina.
Novo Holdings, the controlling shareholder of Novo Nordisk, announced in February 2024 its $16.5 billion acquisition of CDMO giant Catalent. In a related $11 billion deal, Novo Holdings plans to sell three of Catalent’s sites to Novo Nordisk to help expand production of its GLP-1 drugs.
However, the Novo Holdings-Catalent buyout is facing opposition. Earlier this month, Sen. Elizabeth Warren (D-Mass.) urged Federal Trade Commission Chair Lina Khan to “carefully scrutinize” the Catalent deal which, if allowed to push through, will give Novo “unprecedented visibility into and control over its competitor’s production capacity, costs, and business practices.”
Lilly CEO David Ricks said in a Q2 earnings call in August that the company remains concerned about the Novo-Catalent deal. “We’ve aired those concerns publicly and privately since the proposed transaction was announced, and we’re waiting to see what happens,” Ricks told analysts.
Last week, Roche CEO Thomas Schinecker urged regulatory authorities to block Novo Holdings’ buyout of Catalent, arguing that the deal would have wide-ranging negative effects on the industry.
“Limiting the competition in this space is not a good idea,” Schinecker said in a media call. However, he insisted that Roche would not be affected by the deal but it “could be a problem for other smaller players,” according to Reuters.
Unions, consumer groups and public interest organizations have also raised concerns about the acquisition, noting in a letter to Khan that the merger “would be harmful to competition across various therapeutic areas.”
