The FDA found that the use of GLP-1s to treat diabetes and obesity do not cause suicidal thoughts or actions in a preliminary review of clinical trials and safety data reported to the agency.

The FDA has spent the past several months evaluating reports of suicidal thoughts and actions reported via the agency’s adverse event reporting system and determined that the reports did not indicate a clear connection to the drugs, underscoring that the data provided are limited and can be influenced by other factors. Similarly, the agency’s review of clinical trials of GLP-1s did not find a link between the drugs and suicidal thoughts and actions.

“However, because of the small number of suicidal thoughts or actions observed in both people using GLP-1 RAs and in the comparative control groups, we cannot definitively rule out that a small risk may exist; therefore, FDA is continuing to look into this issue,” FDA wrote.

The FDA’s conclusion comes after an NIH-funded study published in Nature Medicine earlier this month found that semaglutide carried a lower risk of suicidal ideations compared to other non-GLP-1 obesity medications. A Novo Nordisk spokesperson told Endpoints News at the time that the company will continue to monitor reports of adverse reactions related to Ozempic and Wegovy, including suicidal ideation.

The FDA said it’s continuing to evaluate data further, including a meta-analysis of all clinical trials for GLP-1s and an analysis of post-marketing data in its Sentinel System, which collects large amounts of health data.

Leerink analysts noted that the FDA hasn’t given a timeline for when it will give another update. Meanwhile the European Medicines Agency’s safety committee is still reviewing the data around GLP-1s and the risk of suicidal thoughts and is slated to reconvene in April to discuss further.

The FDA underscores that patients should not stop taking GLP-1s before consulting their doctors and that healthcare professionals should continue monitoring and reporting instances of suicidal thoughts or actions associated with GLP-1s.

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PackGene is a CRO & CDMO technology company that specializes in packaging recombinant adeno-associated virus (rAAV) vectors. Since its establishment in 2014, PackGene has been a leader in the AAV vector CRO service field, providing tens of thousands of custom batches of AAV samples to customers in over 20 countries. PackGene offers a one-stop CMC solution for the early development, pre-clinical development, clinical trials, and drug approval of rAAV vector drugs for cell and gene therapy (CGT) companies that is fast, cost-effective, high-quality, and scalable. Additionally, the company provides compliant services for the GMP-scale production of AAVs and plasmids for pharmaceutical companies, utilizing five technology platforms, including the π-Alpha 293 cell AAV high-yield platform and the π-Omega plasmid high-yield platform. PackGene's mission is to make gene therapy affordable and accelerate the launch of innovative gene drugs. The company aims to simplify the challenging aspects of gene therapy development and industrialization processes and provide stable, efficient, and economical rAAV Fast Services to accelerate gene and cell therapy development efforts from discovery phase to commercialization.

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