A Novo Nordisk facility in Denmark where the popular obesity drugs Ozempic and Wegovy are manufactured has been cited by the federal Food and Drug Administration for possible contamination issues – a development that has caught the attention of trial lawyers.
Legal claims against the popular medicines to treat both obesity and diabetes have been filed nationwide, including in California. One California lawsuit alleges a Novo Nordisk diabetes drug, Mounjaro, causes a risk of stomach paralysis and severe gastrointestinal issues among patients.
The science behind the claims against Ozempic and Wegovy will be scrutinized during future multidistrict litigation (MDL) in the Eastern District of Pennsylvania.
The FDA released a form last month documenting concerns at the Novo Nordisk facility in Kalundborg, Denmark, about how water used in the manufacture of drugs was not adequately monitored for “objectionable organisms.” The FDA report indicates that sampling is not sufficient to ensure appropriate quality standards and purity.
“Laboratory controls do not include the establishment of scientifically sound and appropriate sampling plans designed to assure that production cultures conform to appropriate standards of identity, strength, quality and purity,” the report based on an inspection in March states.
A Novo Nordisk spokesperson told the Southern California Record in an email the manufacturing process cited by the FDA had to do with Awiqli, the brand name of a once-weekly drug called insulin icodec that is used to treat types of diabetes in the European Union, Canada, Australia, Japan and Switzerland.
“This is the manufacturing process we referred to when we received the CRL (complete response letter) for Awiqli from the FDA in July,” the spokesperson said. “We continue to be in contact with the FDA and do not expect to resolve (the issue) … related to Awiqli this year.”
A CRL is a response from the FDA to a drug application that indicates the drug cannot be approved in its present form. Such a letter is not a rejection, but it provides the drug manufacturer with a chance to take steps to correct problems identified by the FDA.
“We believe in the potential of once-weekly basal insulin icodec for those living with diabetes who require basal insulin therapy,” Martin Lange, a Novo Nordisk executive vice president for development, said in July. “We will work closely with the FDA to identify the next steps needed to complete the review so we can provide this novel treatment option to adults living with diabetes.”
In a blog post, the law firm Miller & Zois LLC mentioned the quality-control problems at the Denmark plant and the lack of proper data to ensure the elimination of microorganisms. The plant is one of two in the world that makes semaglutide, the active ingredient in Ozempic and Wegovy, according to the law firm.
“The reason for mentioning this is that they’re repeating the same mistakes – prioritizing maximum production and profit – as they did when they rushed this product to market,” the blog detailing Ozempic litigation filings states.
Novo Nordisk also has a stem cell therapy research and development facility located in Fremont, as well as other offices around California, including Bakersfield, Los Angeles and Irvine.