EU Launches Broader Investigation into Suicide Risks Tied to Weight-Loss Medications

Date: 13 July 2023 Source: update4u.net

The European Union’s drug regulator has expanded its probe into the potential risk of suicidal thoughts associated with a new class of weight-loss drugs. Additionally, an analysis has revealed that most patients discontinue the medications within a year.

On Tuesday, the European Medicines Agency (EMA) announced that it is investigating a potential link between anti-obesity drugs and suicidal thoughts after receiving 150 reports. Initially, the focus was on Novo Nordisk A/S’s Wegovy, Ozempic, and Saxena. However, it remains uncertain whether these incidents are directly related to the drugs or other underlying conditions.

Furthermore, a study conducted by Prime Therapeutics LLC, a pharmacy benefit manager, found that 68% of patients who initiated treatment with GLP-1 drugs for weight loss had stopped taking them after one year.

Following the news, Novo Nordisk’s stock initially declined by 2.5% in early trading in Copenhagen. However, analysts later downplayed the potential risk, resulting in the shares stabilizing by 1 p.m. in New York.

On the other hand, Eli Lilly & Co., which experienced a 3% drop in its stock on Tuesday, saw a slight recovery of 1.1% on Wednesday after the EMA clarified that its review does not include Lilly’s weight-loss shot, Monaro, as it operates differently from the drugs under investigation.

Weight-loss drugs have become popular in the pharmaceutical industry, propelling Novo Nordisk’s shares to the top of the European market. This success has led to shortages and delayed launches in some regions. In a study involving Wegovy, patients achieved an average weight loss of 15%. Companies are now developing more potent formulations to facilitate even greater weight loss.

Evan Sagerman, an analyst at BMO Capital Markets, expressed doubt regarding a connection between GLP-1 drugs and suicidal thoughts or self-harm. He believes that while the investigation highlights a potential concern, no concrete evidence of a link has been established thus far.

The EMA investigation, which began on July 3, is expected to conclude in November.

It is important to note that patients typically need to continue taking these drugs to maintain weight loss. GLP-1 drugs are also commonly used long-term for controlling type 2 diabetes. Prime Therapeutics and Magellan Rx Management analyzed data from 16 million commercially insured individuals in 2021 and found widespread discontinuation of the drugs, along with a $7,727 increase in total healthcare costs per person during the first year of treatment.

Novo Nordisk stated that GLP-1 drugs have been used to treat type 2 diabetes for over 15 years and obesity for 8 years. The company is actively collecting data on its products to ensure patient safety.

On Monday, the EMA reported three adverse events related to Ozempic and Saxenda after receiving reports from the Icelandic Medicines Agency. The cases included two reports of suicidal thoughts and one case of thoughts related to self-injury, specifically linked to Saxenda.

Experts are questioning whether GLP-1 drugs contribute to suicidal ideation or if individuals opting for GLP-1 treatments have a higher predisposition to mental health issues and depression. Sean Wharton, an assistant professor at the University of Toronto and co-author of GLP-1 studies, poses this critical question.

The European regulator has identified five GLP-1 medicines currently under investigation, including dulaglutide, the active ingredient in Lilly’s Trulicity, a blockbuster drug for type 2 diabetes. Amgen Inc. and Pfizer Inc. are also developing similar products, but they have declined to comment on the ongoing investigation.

Lilly has stated that neither Trulicity nor Mounjaro has raised any safety concerns so far. The company plans to respond to the EMA’s inquiry regarding Trulicity as part of its routine regulatory review process.

Seigerman maintains his positive outlook on Lilly’s stock and does not anticipate any impact on Mounjaro. He believes that even if Wegovy receives a label amendment to include suicide risks, it is unlikely to affect demand. Naresh Chouhan, an analyst at Intron Health, shares this sentiment, as stated in a note.

In January, the Israeli newspaper Haaretz reported that some Saxenda users complained of depression, anxiety, and suicidal thoughts. The Israeli Ministry of Health acknowledged receiving several reports of depression and suicidal thoughts related to the drug, but the rate of such reports was low in comparison to its extensive use. The ministry, which lacked sufficient information to establish a causal connection at the time, has not yet responded to the recent request for comment.

Photo: NoVo’s production facilities in Hillard, Denmark, where packets of Wegovy move along a conveyor. Photographer: Carsten Shemberg/Bloomberg

Topics: Profit Loss, Europe

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