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.