By Bhanvi Satija
Dec 20 (Reuters) - The U.S. Food and Drug Administration
on Friday approved Eli Lilly's ( LLY ) weight-loss treatment,
Zepbound, for obstructive sleep apnea, making it the first drug
greenlighted to directly treat patients with the common sleeping
disorder.
The regulator approved the drug for moderate to severe
obstructive sleep apnea in adults with obesity, the company
said.
The approval opens up a wide market of patients for
Lilly at a time when demand for Zepbound is already surging.
It could also strengthen Lilly's case with commercial
insurers and employers, who have previously hesitated to cover
the drug due to its high cost.
Shares of the Indianapolis-based drugmaker were up 1.14% in
after-market trading following the announcement.
Sleep apnea patients stop breathing briefly while sleeping,
disturbing the sleep cycle and causing long-term complications
such as heart conditions. The condition affects roughly one
billion people globally.
"Too often, obstructive sleep apnea is brushed off as 'just
snoring' - but it's far more than that," said Julie Flygare, CEO
of non-profit organization Project Sleep.
Common treatments for the condition include CPAP
machines, which involve wearing a mask over the face while
sleeping, surgery, as well as losing weight.
Zepbound and Lilly's widely used diabetes drug, Mounjaro,
both chemically called tirzepatide, belong to a class of drugs
called GLP-1 agonists.
Originally developed for type 2 diabetes, they also reduce
food cravings and cause the stomach to empty more slowly.
U.S.-based Lilly and Danish rival Novo Nordisk
are testing their blockbuster obesity drugs for a range of
conditions as they race to show that they have other health
benefits.
Regulators can expand approval for medicines if new data
shows them to be effective in other therapeutic areas.
The FDA's approval is based on data from two trials
involving 469 participants, in which Zepbound helped ease
breathing difficulties in patients with moderate to severe
obstructive sleep apnea.
The drugmaker published the full data in June, showing the
drug helped resolve the disorder in up to 52% of patients in
these trials.
Trial data also showed that Zepbound lowered the so-called
biomarkers of sleep apnea, including low blood oxygen and blood
pressure, which can indicate heart disease.
Government-backed Medicare plans for adults aged 65 and
older and those with disabilities are barred from covering
weight-loss treatments, though the Biden administration has
proposed to
expand the coverage
of anti-obesity drugs.
If President-elect Donald Trump's incoming
administration backs the move, the program would be effective
from 2026.
Medicare only began covering Novo Nordisk's
Wegovy after it gained approval for reducing the risk of heart
attacks and strokes in March.