Novo Nordisk is urging the FDA to ban cheaper compounded versions of its drugs, citing safety concerns.
Researchers at Case Western Reserve University School of Medicine have discovered that Novo Nordisk A/S' NVO semaglutide, an ingredient for a well-known diabetes and weight-loss drug, may reduce the risk of Alzheimer's disease in individuals with type 2 diabetes (T2D) when compared to seven other anti-diabetic medications.
Alzheimer's is a progressive brain disorder that impairs memory and cognitive function.
According to the Alzheimer's Association, nearly 7 million Americans aged 65 and older are living with the condition, and it causes more deaths than breast and prostate cancer combined.
Alzheimer's disease, which leads to the deaths of about 120,000 Americans annually, is the seventh-leading cause of death in the U.S., according to the CDC.
The study revealed that T2D patients taking semaglutide had a notably lower risk of developing Alzheimer's, regardless of factors like obesity, gender, or age.
Semaglutide, a glucagon-like peptide receptor (GLP-1R) agonist that aids in regulating blood sugar and suppressing appetite, is the active ingredient in the widely prescribed drugs Wegovy and Ozempic.
Led by biomedical informatics professor Rong Xu, the research team analyzed three years of electronic health records from nearly 1 million U.S.
The results showed that patients on semaglutide had a significantly reduced risk of Alzheimer's compared to those taking any of seven other diabetes drugs, including other GLP-1R-targeting treatments.
Xu noted that while preclinical studies have hinted at semaglutide's potential to protect against neurodegeneration and neuroinflammation, this study provides real-world evidence of its possible impact on Alzheimer's.
However, Xu emphasized that while the findings are promising, they do not establish a definitive cause-and-effect relationship. "Our study underscores the need for further research through randomized clinical trials to explore semaglutide and other drugs as potential treatments for this debilitating disease," she said.
A Phase 2b clinical trial presented at the Alzheimer's Association International Conference 2024 reveals that Novo Nordisk's older generation GLP-1 drug, liraglutide, may slow cognitive decline by protecting the brain.
A study conducted by the University of Oxford revealed that patients who used Ozempic had a 48% lower risk of dementia compared to those who used an older drug, sitagliptin.
The company has petitioned the FDA to ban compounding pharmacies from producing cheaper, unapproved versions of its drugs Wegovy and Ozempic.
Novo Nordisk argues that these compounded versions may pose safety risks, such as impurities and incorrect dosages, and sometimes lack the active ingredient entirely.
Amid shortages and rising demand for branded drugs, compounded semaglutide has gained popularity due to its affordability.
However, Novo Nordisk contends that only FDA-approved versions should be available, emphasizing the safety risks associated with compounded drugs.
The FDA has supported these concerns and is reviewing the company's petition, the CNBC report added.
Price Action: NVO stock is down 1.26% at $114.29 at last check Thursday.
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