The U.S. Food and Drug Administration has approved Lilly’s GLP-1 pill Foundayo (orforglipron).
On April 1 the FDA approved Foundayo for use in adults with obesity or who are overweight with at least one weight-related comorbid condition.
The once-daily tablet has a starting dosage of 0.8 mg, which should increase to 2.5 mg at 30 days and 5.5 mg after another 30 days. Some patients may require further increases to 9, 14.5 or 17.2 mg.
The approval comes after two randomized, double-blind, placebo-controlled trials which, after 72 weeks of treatment combined with a reduced-calorie diet and increased physical activity, led to clinically meaningful weight loss, the FDA said.
Lilly said adults in that trial lost an average of 27 pounds on the highest dose.
Foundayo will be available immediately and was to start shipping April 6 through LillyDirect starting at about $25 a month with insurance and $149 for self-pay for the lowest dose, Lilly said.
It will be the second oral GLP-1 pill, joining Novo Nordisk’s Wegovy pill, which was approved by the FDA late last year.