EU Drug Regulator Scrutinizes Novo Nordisk and Eli Lilly Over GLP-1 Safety

EU Drug Regulator Scrutinizes Novo Nordisk and Eli Lilly Over GLP-1 Safety

The increased inspection of GLP-I therapies by the European Medicines Agency (EMA) has raised a warning about the possibility that the diabetes and obesity medications might lead to cancer.

The action is the regulator’s first step towards tracking any potential adverse occurrences that could be connected to the usage of licenced medications. According to Novo Nordisk, the EU informed them of the signal last month. 

According to Reuters, Eli Lilly, AstraZeneca, and Sanofi are among the other companies mentioned for their GLP-I drugs.

“Novo Nordisk is aware of the signal and the request by EMA and will deliver a thorough assessment of all relevant data to elucidate this topic,” the company said in a statement. 

The announcement comes as Novo Nordisk and Lilly deal with a huge demand for their medications for Type II diabetes and obesity.

Analysts at ODDO BHF predicted that sales of Novo’s Ozempic and Wegovy will total $15.3 billion this year following good first-quarter performance. 

Mounjaro, a medication for Type II  diabetes that Lilly has experienced success with, is also likely to be approved shortly for obesity. According to the corporation, Mounjaro will generate $3 billion in revenue this year.

The possibility of users acquiring thyroid cancer is already included in the drug’s boxed warning in the United States.

“GLP- I receptor agonists as a drug class have been used to treat type II diabetes for more than 15 years,” Novo added. “The safety data collected from large clinical trial programs and post-marketing surveillance have not demonstrated a causal association between semaglutide or liraglutide and thyroid cancer.”

Following the recommendation of the Pharmacovigilance Risk Assessment Committee (PRAC), the European Union (EU) issued a signal regarding GLP-1 treatments. The companies involved have been given until July 26 to provide additional information in response to the signal. The PRAC also identified other drugs to monitor, including Moderna and Pfizer’s COVID-19 vaccines, Spikevax and Comirnaty, for autoimmune skin conditions.

The news had an initial impact on Novo’s shares in the Copenhagen market, causing a 2% decline. However, the shares recovered in the afternoon, nearly reaching the closing level of the previous day. On the New York Stock Exchange, Novo’s shares continued to rise on Thursday, showing an overall increase of 50% over the past 12 months.

On the other hand, Eli Lilly’s shares were unaffected on Thursday and saw a 2% rise by late morning. Similar to Novo, Lilly’s share price has also increased by 50% over the past year.

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