Pharmaceutical company Eli Lilly and Company (NYSE:LLY) announced on Wednesday that the US Food and Drug Administration (FDA) has approved Foundayo (orforglipron) for adults with obesity, or overweight with weight-related medical problems.

According to Lilly, when used alongside a reduced-calorie diet and increased physical activity, Foundayo helps individuals lose excess body weight and keep the weight off. Foundayo will be available through LillyDirect, with prescriptions accepted immediately and shipping beginning April 6, followed shortly after by broad availability through US retail pharmacies and telehealth providers.

In the ATTAIN-1 trial, individuals taking the highest dose of Foundayo and who stayed on treatment lost an average of 27.3 pounds (12.4%) compared to 2.2 pounds (0.9%) with placebo. Participants taking Foundayo, regardless of trial completion, lost an average of 25 pounds (11.1%), compared to 5.3 pounds (2.1%) with placebo. Foundayo also led to reductions in many markers of cardiovascular risk, including waist circumference, non-HDL cholesterol, triglycerides and systolic blood pressure across all doses.

Foundayo is a once-daily GLP-1 pill that can be taken any time of day without food or water restrictions.

Lilly has submitted orforglipron for weight management and/or type 2 diabetes in more than 40 countries, and plans to launch in each country shortly after approval.