Novo Nordisk, Eli Lilly face scrutiny from EU's drug regulator over GLP-1 safety

The European Medicines Agency (EMA) has ramped up its scrutiny of GLP-1 treatments, raising a safety signal about the potential risk that the diabetes and obesity drugs could cause cancer.

The move is a first step for the regulator in monitoring the potential for adverse events that could be related to use of approved drugs. The EU notified Novo Nordisk about the signal last month, the company told Danish news outlet B.T.  

Other companies flagged for their GLP-1 products include Eli Lilly, AstraZeneca and Sanofi, Reuters reports.

"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 news comes as Novo Nordisk and Lilly face overwhelming demand for their Type 2 diabetes and obesity treatments.

After a strong first quarter of sales for Novo’s Ozempic and Wegovy, analysts at ODDO BHF projected sales of the two GLP-1 drugs will reach a combined $15.3 billion this year. 

Lilly has seen a similar boost for Type 2 diabetes treatment Mounjaro, which is also likely to be authorized soon for obesity. The company projects Mounjaro’s sales will reach $3 billion this year.

The drug already carries a boxed warning in the U.S. about the potential risk of users developing thyroid cancer.

"GLP-1 receptor agonists as a drug class have been used to treat type 2 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."

The EU issued its signal about GLP-1 treatments at the recommendation of the Pharmacovigilance Risk Assessment Committee (PRAC). Each of the companies has been tasked to provide supplementary information by July 26.

In the same report, the PRAC also identified several other drugs to monitor, including Moderna and Pfizer’s COVID-19 vaccines Spikevax and Comirnaty, both for autoimmune skin conditions pemphigus and pemphigoid.

With the news, Novo’s shares on the Copenhagen market fell by 2% but rallied in the afternoon to nearly the level of close on Wednesday. In New York, Novo’s shares continued to climb on Thursday. Over the last 12 months, they are up 50% on the New York Stock Exchange.

Eli Lilly’s shares were unaffected on Thursday as they rose by 2% by late in the morning. Lilly’s share price also has risen by 50% over the last 12 months.  

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