Lilly’s weight-loss therapy Zepbound turns into first FDA-approved drug for sleep apnea

By Bhanvi Satija

(Reuters) -The U.S. Meals and Drug Administration on Friday accredited Eli Lilly (NYSE:LLY)’s weight-loss therapy, Zepbound, for obstructive sleep apnea, making it the primary drug greenlighted to instantly deal with sufferers with the frequent sleeping dysfunction.

The regulator accredited the drug for reasonable to extreme obstructive sleep apnea in adults with weight problems, the corporate mentioned.

The approval opens up a large market of sufferers for Lilly at a time when demand for Zepbound is already surging.

It may additionally strengthen Lilly’s case with business insurers and employers, who’ve beforehand hesitated to cowl the drug as a result of its excessive value.

Shares of the Indianapolis-based drugmaker have been up 1.14% in after-market buying and selling following the announcement.

Sleep apnea sufferers cease respiration briefly whereas sleeping, disturbing the sleep cycle and inflicting long-term issues resembling coronary heart situations. The situation impacts roughly one billion folks globally.

“Too typically, obstructive sleep apnea is dismissed as ‘simply loud night breathing’ – nevertheless it’s excess of that,” mentioned Julie Flygare, CEO of non-profit group Challenge Sleep.

Frequent therapies for the situation embody CPAP machines, which contain carrying a masks over the face whereas sleeping, surgical procedure, in addition to shedding weight.

Zepbound and Lilly’s broadly used diabetes drug, Mounjaro, each chemically referred to as tirzepatide, belong to a category of medicine referred to as GLP-1 agonists.

Initially developed for kind 2 diabetes, in addition they cut back meals cravings and trigger the abdomen to empty extra slowly.

U.S.-based Lilly and Danish rival Novo Nordisk (NYSE:NVO) are testing their blockbuster weight problems medicine for a variety of situations as they race to indicate that they produce other well being advantages.

Regulators can develop approval for medicines if new information exhibits them to be efficient in different therapeutic areas.

The FDA’s approval relies on information from two trials involving 469 individuals, by which Zepbound helped ease respiration difficulties in sufferers with reasonable to extreme obstructive sleep apnea.

The drugmaker printed the complete information in June, exhibiting the drug helped resolve the dysfunction in as much as 52% of sufferers in these trials.

Trial information additionally confirmed that Zepbound lowered the so-called biomarkers of sleep apnea, together with low blood oxygen and blood strain, which might point out coronary heart illness.

Authorities-backed Medicare plans for adults aged 65 and older and people with disabilities are barred from masking weight-loss therapies, although the Biden administration has proposed to develop the protection of anti-obesity medicine.

If President-elect Donald Trump’s incoming administration backs the transfer, this system could be efficient from 2026.

Medicare solely started masking Novo Nordisk’s Wegovy after it gained approval for decreasing the danger of coronary heart assaults and strokes in March.