FDA orders new warning on GLP-1 drugs over rare eye condition

The FDA is requiring warnings on GLP-1 drugs, including Novo Nordisk's Ozempic and Wegovy and Eli Lilly's Mounjaro, due to a potential link to a rare eye condition, NAION. The FDA's decision follows an analysis of clinical trials and patient data. Citi analysts expect limited impact on drug usage despite the new warning.

The FDA ordered warnings for GLP-1 drugs, including Eli Lilly's Mounjaro, Zepbound, and Novo Nordisk's Ozempic, Wegovy, about rare vision-loss risks. Despite this, shares of Eli Lilly and Novo Nordisk rose 4.3% and 2.7% respectively. Lilly's Q3 earnings showed strong sales of $10.7B for Mounjaro and $5.4B for Zepbound, accounting for two-thirds of its revenue. Novo raised its full-year outlook but expects flat sales growth.

Novo Nordisk's ziltivekimab and Novartis' pelacarsen failed to reduce cardiovascular events in trials, despite lowering inflammation and Lp(a) levels. Novo Nordisk will discontinue ziltivekimab development and recorded a DKK 4.6B impairment. Novartis is also halting pelacarsen's development. Both companies are exploring other trials or drugs.

Novartis' pelacarsen and Novo Nordisk's ziltivekimab failed to reduce cardiovascular events despite targeting Lp(a) and inflammation. Novartis' drug, tested on 8,300 patients, showed no benefit in preventing heart attacks or strokes. Novo Nordisk's trial on 6,300 patients also showed no reduction in major cardiovascular events. Both companies presented findings at the American Heart Association meeting.

Eli Lilly's oral GLP-1 drug, Foundayo, was approved, marking a shift in the GLP-1 receptor targeting discussion. Analysts project significant sales, with Fidelity estimating $1.5bn-$2.8bn in 2026 and Citi forecasting peak revenues over $40bn. The approval opens the door for more small-molecule GLP-1 agonists, potentially creating a new drug class.

Novo Nordisk (NOVO B) received an FDA warning about a rare vision loss risk associated with its GLP-1 drugs, including Wegovy. The FDA is requiring label updates based on clinical trials and real-world reports. Novo Nordisk has a market cap of DKK1.2 trillion and focuses on treatments for chronic conditions. The warning may impact the company's margins and legal exposure, but it does not alter the core growth prospects for its GLP-1 portfolio.