Catalent’s Brussels factory, responsible for filling the self-injection pens for Novo Nordisk’s obesity blockbuster Wegovy, suffered a number of lapses in recent years and had to shut down twice, according to a new Reuters report, which cites FDA documents stemming from a series of inspections.
The plant's shutdowns occurred between October 2021 and August 2022, according to the report.
In November 2022, the FDA published a final decision on its findings and allowed the factory to remain open while Catalent carried out remediation efforts, Reuters adds, citing FDA documents.
Catalent’s need to address shortfalls at the plant led to delays in shipments of Wegovy throughout 2022, the CDMO and Novo Nordisk have said publicly.
The most serious findings unearthed by the FDA during its October 2021 visit had to do with air filtration systems used to maintain sterile conditions, according to Reuters. Inspectors found that the system on one filling line at the plant had repeatedly failed between 2017 and 2021, leading to “compromised” sterility in the area where drug products were being produced.
Meanwhile, Novo Nordisk has been grappling with supply constraints on Wegovy since the med’s launch in mid-2021.
After promising a supply boost of Wegovy in April, the company the following week said it was “temporarily” reducing U.S. supply of lower dosage strengths to “safeguard continuity of care.”
The company saw a "short-term need” to cut back on starter doses of the drug,” CEO Lars Fruergaard Jørgensen said on the company’s first-quarter earnings call this spring. The CEO added that manufacturing is now “running well” and that the reduction would play out over a “limited period."
Further, Novo has paused key promotional efforts on Wegovy in an effort to get ahead of intense demand.
More recently, supplies of the company’s weight loss predecessor drug, Saxenda, started to run short, with supply constraints expected to last through the end of 2023.