(Bloomberg) -- Eli Lilly & Co.’s weight-loss and diabetes drug Mounjaro won’t be reclassified as a sleep apnea treatment in Europe, with regulators saying Friday that use of the drug is already covered in its approval as a weight-loss medicine.
Data the drugmaker filed on sleep apnea can be included in Mounjaro’s product information, the European Medicines Agency said on Friday. That will allow doctors to be aware of its effects, the agency said.
Getting approval for weight loss medicines in new treatment areas is a key part of the strategy for Eli Lilly and its Danish rival Novo Nordisk A/S, maker of Ozempic and Wegovy. The two companies are locked in a battle for control of the growing market for obesity drugs, which some analysts estimate could reach $130 billion in annual sales by the end of the decade.
Lilly shares were little changed in trading before the market open in New York.
In a pair of large sleep apnea studies, Lilly’s shot reduced the number of times breathing slowed or stopped during sleep by as much as 63% from baseline, the company said earlier this year. The Food and Drug Administration is also reviewing whether to expand its use to sleep apnea.
The condition affects about one-third of men in the US and a far larger percentage in some other countries, including Germany, Switzerland and Japan, researchers have said in The Lancet Respiratory Medicine.
Mounjaro is sold under the brand name Zepbound as an obesity treatment in the US. In Europe, it’s branded as Mounjaro for both diabetes and obesity. Lilly has said it plans to test the drug for everything from alcohol use disorder to psoriasis and heart failure.
--With assistance from Madison Muller.
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