Diet drug Zepbound reduces sleep apnea severity

[New Sancai Compilation First Release] Eli Lilly and Company said its weight-loss drug helped reduce episodes of irregular breathing associated with a common sleep-related disorder in two late-stage trials, paving the way for expanded use of the drug. In two studies, the drug reduced the frequency of irregular breathing episodes by 63%.

The trial results add to a growing body of clinical evidence that popular GLP-1 drugs such as Eli Lilly and Company's Zepbound and Novo Nordisk's Wegovy have medical benefits beyond diabetes and weight loss.

The U.S. Food and Drug Administration approved Wegovy last month to reduce the risk of stroke and heart attack in overweight or obese adults who do not have diabetes. The Indianapolis-based drugmaker's shares rose 1.6% to $758.64 in early trading. Eli Lilly's shares have risen 26% since January. Eli Lilly is evaluating its GLP-1 drug called tirzepatide, sold as Zepbound for obesity and Mounjaro for type 2 diabetes, in patients with obstructive sleep apnea and obesity.

In the first study, patients treated with tilsiparatide experienced a 55% reduction in the frequency of episodes of irregular breathing. A second study tested the drug in combination with continuous positive airway pressure (PAP) therapy, and patients experienced an average 62.8% reduction in irregular breathing events.

Wall Street analysts said the data could increase Eli Lilly's chances of winning coverage under the U.S. government-backed Medicare program for seniors.

Obstructive sleep apnea, characterized by brief interruptions in breathing during sleep, affects about 1 billion people worldwide, according to a 2019 study published in The Lancet. There are currently no drugs approved to treat this condition, although the use of PAP therapy devices (which provide constant air pressure to prevent airway collapse) is common.

ResMed's continuous PAP treatment device has received FDA approval. Eli Lilly plans to begin submitting materials to the U.S. FDA and other regulatory agencies in mid-2024. Analysts said the data could help Eli Lilly win approval for Zepbound in early 2025 to treat sleep apnea and obesity.

Analysts said that once the full data are released, they want to see if Zepbound shows additional benefits beyond weight loss, such as any improvement in patients' blood pressure levels - one of the secondary goals of Eli Lilly's study. Investors are also interested in knowing whether the drug "is effective in thin people with the disease."

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Eli Lilly said that in these two studies, men accounted for about 70% of the patient population, and the weight loss effect in men treated with incretins such as tilsiparatide was lower than that in women. The results could provide Eli Lilly with a way to increase use of its drug in men.

Eli Lilly did not provide detailed results on the study's secondary objectives but said it planned to present detailed data at a medical meeting in June. Zepbound was approved late last year for chronic weight management in overweight patients with at least one comorbid condition, such as obstructive sleep apnea or cardiovascular disease.

(Compiled by: Wang Jimin)

(Editor: Jiang Qiming)

(Source of the article: Compiled and published by New Sancai)