The European Union’s drug regulator expanded its investigation into a possible risk of suicidal thoughts associated with a new class of weight-loss medicines and a separate analysis found that most patients stopped taking the medications after a year.
(Bloomberg) — The European Union’s drug regulator expanded its investigation into a possible risk of suicidal thoughts associated with a new class of weight-loss medicines and a separate analysis found that most patients stopped taking the medications after a year.
The European Medicines Agency said Tuesday it’s probing a possible risk of suicidal thoughts associated with anti-obesity drugs after receiving 150 reports. Initially the focus was on side effects linked to Novo Nordisk A/S’s Wegovy, Ozempic and Saxenda, according to a statement Tuesday. It isn’t clear whether the incidents were related to the drugs or other underlying conditions.
Meanwhile a study by pharmacy benefit manager Prime Therapeutics LLC found that 68% of patients who newly started taking GLP-1 drugs for weight loss were no longer taking them after one year.
Novo’s stock dropped as much as 2.5% in Copenhagen in early trading Wednesday, then pared back losses as analysts downplayed the potential risk to the blockbuster obesity shot. The shares were little changed at 1 p.m. in New York.
Eli Lilly & Co. closed down 3% Tuesday in New York, then rose as much as 1.1% Wednesday after the EMA said its review doesn’t include the company’s weight-loss shot Mounjaro as it works differently from the drugs being investigated.
Weight-loss drugs have joined the hottest sellers in pharma, driving Novo’s shares to the top of the European industry heap, and leading to shortages and delayed launches in some markets. In one study of Wegovy, patients lost an average of 15% of their body weight, and companies are developing more powerful formulations that can help people shed even more pounds.
“I don’t think there’s any link,” between GLP-1s and thoughts of suicide or self-harm, said Evan Seigerman, an analyst at BMO Capital Markets. “I think it is clearly something highlighting a potential concern but we have yet to have any actual link.”
The EMA investigation began July 3 and is expected to conclude in November, the agency said.
Longtime Use
Patients typically have to continue taking the drugs in order to keep the weight off. GLP-1 drugs are also used long-term for type 2 diabetes control. Prime Therapeutics and Magellan Rx Management analyzed data from 16 million commercially insured members in 2021 and found signs of widespread discontinuation of the drugs along with an increase of $7,727 per person in total health-care costs in the first year of taking them.
GLP-1 drugs have been used to treat type 2 diabetes for more than 15 years and for obesity for 8 years, Novo said. The company said it’s collecting data on its products to ensure patient safety.
The EMA said Monday that it was looking at three adverse events in connection with Ozempic and Saxenda after receiving reports from the Icelandic Medicines Agency. Two cases of suicidal thoughts were reported to the EMA relating to the drugs, with another linked to thoughts of self-injury raised in connection with Saxenda.
“Is the GLP-1 leading to suicide or do the people choosing to use GLP-1s have a higher propensity for mental health issues and depression? That’s the question,” said Sean Wharton, an assistant professor at the University of Toronto who has co-authored studies of GLP-1s.
Five Medicines
The European regulator named five GLP-1 medicines that are being investigated, including dulaglutide, the active ingredient in Lilly’s blockbuster drug Trulicity for type 2 diabetes. Companies including Amgen Inc. and Pfizer Inc. are also developing similar products. The two US drugmakers declined to comment.
Lilly said it hasn’t identified a safety signal with either Trulicity or Mounjaro. The company plans to respond to the EMA inquiry of Trulicity “as part of our routine regulatory review processes,” according to an emailed statement.
Seigerman said he doesn’t see an impact on Lilly’s Mounjaro, and that he’s maintaining his outperform rating on Lilly’s stock. Lilly didn’t immediately respond to a request for comment.
Even if Wegovy gets a label amendment to warn of suicide risks, “that is unlikely to impact demand,” Naresh Chouhan, an analyst at Intron Health, wrote in a note.
The Israeli newspaper Haaretz reported in January that some Saxenda users were complaining of depression, anxiety and suicidal thoughts. Israel’s Ministry of Health told the outlet that “several reports of depression and suicidal thoughts during use of the drug have been received, but the rate of reports is low compared to the extent of use.”
The health ministry said then that it lacked sufficient information to determine a causal connection. It didn’t immediately respond to a request for comment.
–With assistance from Jonas Ekblom, Naomi Kresge and Deirdre Hipwell.
(Updates with Lilly comment in 14th paragraph.)
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