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EU drugs regulator backs Mounjaro's sleep apnea use without fresh approval for Lilly
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EU drugs regulator backs Mounjaro's sleep apnea use without fresh approval for Lilly
Dec 13, 2024 6:50 AM

Dec 13 (Reuters) - The European Medicines Agency has

allowed Eli Lilly ( LLY ) to update the product label of its

weight-loss drug Mounjaro to show it has benefit in treating a

sleep disorder without approving it specifically for the

disease, the company said.

Lilly was seeking EU approval for the expanded use of

Mounjaro to treat moderate to severe obstructive sleep apnea

(OSA) in patients with obesity.

The EMA said it did not believe the company needs a separate

approval, highlighting that the disorder was closely related to

obesity.

"OSA and obesity are two diseases that often overlap; about

58% of people with moderate to severe  OSA have excess weight,"

Lilly said.

In two trials involving 469 participants, Lilly's drug

helped cut the frequency of irregular breathing in patients by

as much as 63%, the company reported in April.

Lilly is also seeking approval for the drug in sleep apnea

patients in the U.S.

Lilly and Danish rival Novo Nordisk are racing to

show that their obesity drugs also have other medical benefits.

Approval for use beyond weight-loss could be a shot in the arm

for the companies at a time when demand for the drugs is already

surging.

Obstructive sleep apnea affects roughly 1 billion people

globally, according to a 2019 study published in The Lancet.

Common treatments include CPAP machines, which involve

wearing a mask over the face while sleeping, surgery, as well as

losing weight.

Tirzepatide is sold as Mounjaro in Europe and is approved

for patients with obesity and type 2 diabetes. Regulators can

allow expanded use of treatments if new evidence shows them to

be effective in new therapeutic areas.

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