Concerns are mounting over experimental weight-loss medicines as retatrutide prescribing draws scrutiny and survodutide data raises tolerability questions.
Safety questions around experimental weight-loss drugs are drawing new attention, with CBS News reporting concerns over doctors prescribing retatrutide, a treatment that has not been approved by the Food and Drug Administration and is not yet on the market.
The concern comes as demand for obesity medicines has surged and companies race to develop the next generation of treatments. Retatrutide has been described in CBS reporting as showing strong results in trials compared with current options, but the treatment remains experimental.
The scrutiny is not limited to one drug. Shares of Danish drugmaker Zealand Pharma fell sharply Monday after new data on another experimental weight-loss medicine, survodutide, raised questions about side effects even though the drug met its main study goals.
Zealand said survodutide, which it licensed to privately held Boehringer Ingelheim, met key targets in a late-stage study. But 19% of patients stopped treatment because of gastrointestinal events, compared with 2.9% of patients on placebo, according to CNBC’s report on the data.
Barclays analysts summed up the concern in a note cited by CNBC: “Safety/tolerability remains the key issue.” The analysts said the discontinuation rate and reports of vomiting could limit the drug’s commercial prospects for obesity or fatty liver disease.
CNBC reported that more than 40% of patients in the study experienced vomiting. Citi analysts also flagged nausea, vomiting, diarrhea and constipation rates as commercially significant when compared with rival obesity drugs.
Survodutide was tested over 76 weeks in adults living with obesity or adults who were overweight, without type 2 diabetes. Topline data released in April showed average weight loss of up to 16.6%, compared with 3.2% for placebo.
The market is currently led by Novo Nordisk’s semaglutide products, including Wegovy and Ozempic, and Eli Lilly’s tirzepatide products, including Zepbound and Mounjaro. A broad field of drugmakers is trying to compete by developing treatments that may offer different benefits, including muscle preservation, oral dosing or effects on obesity-related conditions.
For patients and clinicians, the latest reports underscore a central tension in the fast-moving weight-loss drug market: strong trial results may generate excitement, but approval status and tolerability remain critical questions. The next updates to watch are further clinical data, regulatory decisions and any additional guidance around use of drugs that remain experimental.
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