By Christy Santhosh and Bhanvi Satija
(Reuters) -The European Medicines Agency has allowed Eli Lilly 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.
(Reporting by Christy Santhosh and Bhanvi Satija in Bengaluru; Editing by Shailesh Kuber)
