Eli Lilly and Co (NYSE:LLY) announced that the U.S. Food and Drug Administration (FDA) has approved Foundayo (orforglipron) for adults with obesity or those who are overweight with weight-related medical conditions, sending its shares more than 5% higher on Wednesday afternoon.
The approval marks Lilly’s second FDA-approved medication for obesity.
Foundayo is a once-daily oral GLP-1 receptor agonist that can be taken at any time of day without food or water restrictions.
The company plans to make the medication available through LillyDirect, offering free home delivery starting at $25 per month for commercially insured patients and $149 for self-pay individuals. Broad availability through retail pharmacies and telehealth providers will follow.
Clinical data from the ATTAIN-1 trial indicate that participants on the highest dose of Foundayo lost an average of 27.3 pounds (12.4% of body weight) compared with 2.2 pounds (0.9%) in the placebo group.
Across all participants, the drug led to an average weight loss of 25 pounds (11.1%), compared with 5.3 pounds (2.1%) for placebo.
The program also showed reductions in cardiovascular risk markers, including waist circumference, cholesterol, triglycerides, and blood pressure.
Eli Lilly CEO David Ricks highlighted that Foundayo aims to increase access to obesity treatment, highlighting that currently fewer than one in ten eligible patients use a GLP-1 therapy.
“We believe Foundayo can help level the playing field for those living with obesity or who are overweight and living with weight-related complications," Ricks said.
"As a convenient, once-daily oral pill that delivers meaningful weight loss, this is obesity care designed for the real world."