A US judge has rejected efforts by a compounded drugs industry group to keep making an alternative version of Novo Nordisk’s popular drug semaglutide, opening the door for the US Food and Drug Administration (FDA) to take enforcement action.
US District Judge Mark Pittman in Texas denied a preliminary injunction bid by the Outsourcing Facilities Association (OFA), which argued against the FDA’s conclusion that the semaglutide shortage was resolved in mid-February, as per court records reported by Reuters.
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Steve Benz, Novo Nordisk’s legal and US general counsel corporate vice president, said the “extensive nationwide legal actions we have taken to protect Americans from the health risks posed by illegitimate ‘semaglutide’ drugs are working”, adding that the company “will continue driving these actions forward and escalate our efforts as necessary, while closely engaging with regulators and law enforcement.”
OFA did not immediately respond to Pharmaceutical Technology’s request for comment.
Novo Nordisk sells semaglutide under the brands Wegovy and Ozempic for weight loss and type 2 diabetes treatment, respectively. Compounding pharmacies were allowed to produce vast quantities of copies of the drug when semaglutide was in short supply starting in early 2022.
Novo Nordisk has spent considerable money in boosting its manufacturing capabilities and reinforcing supply chains to meet the soaring demand for its blockbuster drug in recent years. When declaring the shortage over in February, the FDA set deadlines for pharmacies and outsourcing facilities to cease production in April and May, respectively.
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By GlobalDataThat same month, OFA sued the FDA claiming that the semaglutide shortage was not over, contrary to data analysed by the agency. In the lawsuit, OFA described the decision as “reckless and arbitrary” that would deprive patients of much-needed medication.
It remains to be seen what action the FDA will now take. Previously, it stated it would not pursue any enforcement until the court ruling.
This case is just the latest in a long-running legal saga between GLP-1RA developers and compounders as they grapple for their own share of the weight loss market worth tens of billions of dollars. Telehealth platforms such as Hims & Hers have surged in popularity as patients sought access to weight loss drugs. Through Novo Nordisk’s eyes, this has been to the detriment of the financial outlook for their prized drug.
Some of these companies, such as Mochi Health, have maintained that they will continue to sell GLP-1RAs under personalised treatment plans. This approach, which lets them skirt around FDA rules, has been the subject of lawsuits by both Novo Nordisk and rival Eli Lilly. The latter, which sells tirzepatide under the brand names Zepbound and Mounjaro for weight loss and type 2 diabetes, respectively, claims that telehealth companies are conducting “deceptive marketing”.
