Europe's regulator says Mounjaro label can cover sleep apnea without a new approval

Europe's medicines regulator has allowed Eli Lilly to update the label of its obesity drug Mounjaro to reflect a benefit in obstructive sleep apnea, without granting the drug a separate approval for the sleep disorder ^[1].

The European Medicines Agency said it did not believe Lilly needed a separate approval, noting that the sleep disorder is closely related to obesity ^[1]. Lilly had asked European regulators to approve an expanded use of Mounjaro for moderate to severe obstructive sleep apnea in patients with obesity ^[1].

"OSA and obesity are two diseases that often overlap; about 58% of people with moderate to severe OSA have excess weight," Lilly said ^[1].

The company reported in April that in two trials involving 469 participants, Mounjaro reduced the frequency of irregular breathing by as much as 63% ^[1]. Details such as how that figure was measured and what it was compared against have not been reported ^[1].

Obstructive sleep apnea affects roughly 1 billion people globally, according to a 2019 study published in The Lancet ^[1]. Common treatments include CPAP machines, which involve wearing a mask over the face while sleeping, surgery and weight loss ^[1].

Mounjaro contains the molecule tirzepatide and is approved in Europe for patients with obesity and type 2 diabetes ^[1]. Regulators can allow expanded use of treatments when new evidence shows them to be effective in new therapeutic areas ^[1].

Lilly is also seeking approval for the drug in sleep apnea patients in the United States ^[1]. The company is racing Danish rival Novo Nordisk to show that obesity drugs have medical benefits beyond weight loss ^[1].

Why it matters for patients

The EMA action applies to the European product label, not to any U.S. approval ^[1]. For U.S. patients, the relevant item is the separate application Lilly has said it is pursuing with U.S. regulators for sleep apnea use ^[1].

A label that mentions sleep apnea benefits gives doctors and patients in Europe information that was not previously on the document, in a condition that frequently appears alongside obesity ^[1]. It does not mean the drug is approved as a stand-alone sleep apnea treatment in Europe, because the agency decided a separate approval was unnecessary ^[1].

Whether insurers or national health systems will pay for tirzepatide specifically to treat sleep apnea has not been reported ^[1]. The source also does not describe how the 63% reduction compares with existing sleep apnea treatments such as CPAP, or what happened to patients who did not respond ^[1].

People already taking tirzepatide for obesity or type 2 diabetes should note that the European decision does not by itself change the drug's approved uses in the United States, and no U.S. decision has been reported ^[1].

What happens next

Lilly has said it is seeking U.S. approval for the drug in sleep apnea patients ^[1]. No timeline for a U.S. decision has been disclosed ^[1].

In Europe, the company has received the labeling change it requested through a route that fell short of a full approval for the sleep condition ^[1]. The EMA's reasoning was that obstructive sleep apnea and obesity overlap closely enough that a separate approval was not required ^[1].

The broader pattern is that Lilly and Novo Nordisk are both trying to show their obesity drugs treat conditions beyond excess weight, a step that could widen their medical use ^[1].