Wegovy gains new approval: 3 GLP-1 updates
Novo Nordisk’s popular weight loss drug, Wegovy, is the first and only GLP-1 medication approved to treat metabolic associated steatohepatitis, a serious condition marked by liver scarring.
The FDA granted the approval Aug. 15.
Injectable GLP-1 drugs primarily treat obesity and Type 2 diabetes, and some have additional indications including cardiovascular disease, kidney disease and obstructive sleep apnea.
Novo Nordisk and Eli Lilly are racing to gain the first FDA approval for an oral GLP-1 for weight loss. Novo Nordisk’s pill version of Wegovy (semaglutide) resulted in 15.1% average weight loss after 68 weeks, while Eli Lilly’s experimental drug, orforglipron, averaged between 10.5% and 12.4% in weight loss after 72 weeks.
Denmark-based Novo Nordisk is also investigating its GLP-1 medications’ uses for treating dementia and Alzheimer’s disease, with phase 3 trial results expected later this year, according to Bloomberg.
Three other updates on the GLP-1 drug class:
1. Texas lawsuit
In August, Texas Attorney General Ken Paxton filed a lawsuit against Eli Lilly alleging it pays kickbacks. The state is seeking more than $1 million from the drugmaker, which the lawsuit accuses of persuading physicians to prescribe 14 of its medications, including GLP-1s such as Mounjaro and Zepbound, through kickbacks.
Eli Lilly said the accusations are “meritless” and said it will “vigorously defend against these allegations.”
2. Research findings
Recent studies have found associations between GLP-1s and increasing testosterone to normal levels; reducing the risk of endometrial, ovarian and meningioma cancers; and decreasing the risk of hospitalization and all-cause mortality among heart failure patients.
Other research found a modest risk of GLP-1 users developing a retinal and optic nerve condition, diabetic retinopathy.
3. Drugmakers go direct-to-consumer
Eli Lilly has partnered with Chinese digital healthcare platform JD Health International to sell its GLP-1s to patients online, Bloomberg reported Aug. 29. The partnership will offer virtual consultations, prescriptions, drug delivery and follow-up care in an effort to increase access.
A few weeks prior, Novo Nordisk announced its collaboration with GoodRx to slash Ozempic’s price in half, from $997 to $499 for a four-week supply, for self-paying patients.
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