AP – On Wednesday, federal regulators approved a new weight-loss pill from Eli Lilly, marking the second daily oral medication available for treating obesity and related conditions.
The Food and Drug Administration (FDA) expedited the approval process for orforglipron, a GLP-1 drug designed to mimic a hormone that naturally controls appetite and satiety, similar to widely used injectable medications.
The medication, to be marketed under the name Foundayo, is set to start shipping on Monday. According to the company, insurance holders could access the drug for as low as $25 monthly with a Lilly discount card. For those paying cash, the cost will range from $149 to $349 per month, depending on the dosage.
This new pill now joins Novo Nordisk’s oral Wegovy pill, which has seen over 600,000 prescriptions in the U.S. since its approval in December.
The FDA’s approval of Eli Lilly’s drug was part of a new initiative to reduce drug approval times. The agency completed the review of the application in 50 days.
A clinical trial involving over 3,000 adults with obesity showed that participants on the highest dose of orforglipron, 36 milligrams, experienced an 11.2% body weight loss, approximately 25 pounds on average, over a period exceeding 16 months.
In contrast, those on a placebo, or dummy pill, lost 2.1% body weight, or less than 5 pounds, as reported by the New England Journal of Medicine.
Both the Lilly and Novo Nordisk pills resulted in less weight loss compared to Lilly’s injectable Zepbound, which sees a 21% average weight loss, and Novo Nordisk’s injectable Wegovy, which averages a 15% weight loss.
Both pills offer daily convenience, yet orforglipron, a small-molecule GLP-1 drug, can be taken without dietary restrictions.
The Wegovy pill, a peptide, requires intake with a sip of water in the morning on an empty stomach, with a 30-minute wait before consuming any food or drink.
Participants taking orforglipron also showed improvements in waist size, blood pressure, triglyceride levels, and cholesterol, according to the study findings.
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Gastrointestinal side effects led to 5% to 10% of participants in the orforglipron trial discontinuing treatment, compared to nearly 3% in the placebo group.
Approximately 1 in 8 Americans have used injectable GLP-1 drugs, according to a survey by KFF, a nonprofit health policy research group, although many struggle to afford these costly injections.
