Eli Lilly (LLY.US) Weight-Loss Oral Drug Foundayo Shows Significant Efficacy in Treating Sleep Apnea; Plans to Seek FDA Approval by Year-End

Eli Lilly (LLY.US) announced on Monday that its once-daily oral weight-loss drug Foundayo significantly reduced the severity of obstructive sleep apnea (OSA) in obese patients in late-stage clinical trials. Eli Lilly plans to submit an application to the U.S. Food and Drug Administration (FDA) before the end of this year, seeking approval of Foundayo for the treatment of moderate-to-severe obstructive sleep apnea in adults who are obese or overweight. As of press time, Eli Lilly's stock price rose more than 3.4% to $1,399.81. This result means that Foundayo is expected to become another GLP-1 drug used to treat sleep apnea. The drug was launched in the United States in April this year and is currently mainly used for weight management. Obstructive sleep apnea is a common sleep-related breathing disorder in which patients repeatedly experience pauses in breathing or reduced breathing during sleep due to narrowing or blockage of the upper airway, which may lead to decreased blood oxygen levels, increased blood pressure, and a higher risk of serious complications such as hypertension, heart failure, and stroke. According to data from the U.S. National Council on Aging, nearly 1 billion adults worldwide are affected by sleep apnea, including about 80 million patients in the United States aged 20 and older. Eli Lilly noted that most patients have not yet been diagnosed. Currently, treatment options for the disease remain limited, and many patients need to use positive airway pressure (PAP) devices to maintain normal breathing during sleep, but such devices are relatively inconvenient to use. In December 2024, Eli Lilly's weight-loss injectable drug Zepbound became the first drug approved by the U.S. FDA for the treatment of obstructive sleep apnea. Now, the positive trial results for Foundayo are expected to further expand Eli Lilly's product portfolio in this therapeutic area. The clinical trial included two independent studies. The first study enrolled 363 patients who were unable or unwilling to use PAP therapy; the second study enrolled 349 patients who had already received PAP therapy for at least three months at screening and continued to use the device during the trial. In both studies, patients in the Foundayo treatment group started at a lower dose and gradually increased the dose at four-week intervals. Researchers mainly evaluated the treatment effect through the apnea-hypopnea index (AHI). This indicator measures the number of apnea or hypopnea events per hour of sleep and is an important criterion for determining the severity of obstructive sleep apnea. Among the patient group not using PAP devices, after 52 weeks of Foundayo treatment, patients experienced an average reduction of 21.1 AHI events per hour, compared with a reduction of only 4.8 events in the placebo group. The Foundayo treatment group showed an overall AHI reduction of 43.8%, significantly better than the 6.3% reduction in the placebo group. In addition, 31.5% of Foundayo users in this group met the criteria for disease remission or improvement in severity to mild. Among the patient group continuing PAP therapy, Foundayo also achieved positive results. Data showed that patients treated with Foundayo in combination with PAP experienced an average reduction of 18.3 AHI events per hour after 52 weeks, compared with an average reduction of 5.5 events in the placebo group. The Foundayo treatment group showed an overall AHI reduction of approximately 27.5%, compared with a reduction of only 3% in the placebo group. In this group, 19.6% of Foundayo users met the criteria for disease remission or improvement to mild. In addition to reducing apnea events, Foundayo also significantly improved patients' oxygen deprivation during sleep. Trial results showed that among patients not using PAP therapy, Foundayo reduced the sleep apnea-related hypoxic burden by 55.9%; among patients continuing to use PAP devices, this indicator decreased by 45.8%. This indicator is mainly used to measure the degree and duration of blood oxygen decline during sleep. In addition, Foundayo also helped patients in both studies achieve about 11% weight loss after 52 weeks and reduced the level of an inflammation-related biomarker. In terms of safety, Eli Lilly stated that the safety and patient tolerability of Foundayo in this study were generally consistent with previous clinical trial results. The most common adverse reactions mainly involved the gastrointestinal tract, including nausea, diarrhea, constipation, and vomiting, and were usually mild to moderate in severity. Among patients not using PAP therapy, about 12% of Foundayo users discontinued treatment due to side effects, compared with 3.8% in the placebo group. Among patients treated with Foundayo in combination with PAP, the proportion discontinuing due to side effects was 6.8%, higher than 0.6% in the placebo group. Thomas Seck, senior vice president of product development for Eli Lilly's cardiometabolic health business, said that Foundayo has already brought positive changes to obese patients, and as the company plans to submit the latest trial results to the FDA before the end of the year, it is expected to further help patients with sleep apnea in the future. If ultimately approved, Foundayo is expected to provide a new oral treatment option for adults who are obese or overweight and have moderate-to-severe obstructive sleep apnea, while further strengthening Eli Lilly's competitive position in the market for obesity and related complications.