The factory that fills injection pens for Novo Nordisk's weight loss drug, Wegovy, has repeatedly failed to comply with United States sterile-safety rules in recent years.
Staff at Catalent, the Brussels-based plant that fills syringes for pharmaceutical clients, have failed to perform required quality checks, according to a Reuters review of regulatory documents.
The FDA inspectors detected the breaches during the visits in October 2021 and August 2022 to check on its compliance with manufacturing regulations.
The most serious violation involved air-filtration systems necessary to maintain sterile conditions. In October 2021, the FDA inspectors found that the system on one filling line at the plant had failed repeatedly between 2017 and 2021, leading to sterility being "compromised" in the area where drug products were being manufactured.
New problems with air quality were detected in August 2022. During both visits, the inspectors found that Catalent staff was not performing the required safety controls, such as regularly checking that equipment was not contaminated with microbes.
Although there is no evidence that breaches resulted in harm to Wegovy's users, they represented the most serious form of violations, documents obtained by Reuters show.
According to the reports, Catalent shut the plant down twice between the two inspections. In November 2022, the FDA published a final decision allowing the factory to remain open while it fixes the issues that the agency did not consider to be a threat to public safety.
Both companies and the FDA declined to comment on the specific inspection findings. Earlier this year, both Novo Nordisk and Catalent said that shipments of Wegovy were delayed following problems raised by the FDA inspections at the plant.
The use of Wegovy in the United States rose to around 135,000 new prescriptions in May 2022 from 45,000 in the last week of January, Barclays Research estimates.
Wegovy, which contains the active ingredient semaglutide, belongs to a class of drugs called GLP-1 receptor agonists. The medications work by increasing the levels of hormones called incretins that help the body produce more insulin and reduce the amount of glucose when needed.
The FDA has approved Wegovy to treat obesity in patients with a body mass index (BMI) greater than 30. It can also be used in overweight individuals with BMI > 27 who have at least one condition related to having excess weight.
In clinical trials, Wegovy reduced body weight in people with a BMI of 27 or greater by around 15% over a 68 weeks period.
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