Eli Lilly and Company has announced that the US Food and Drug Administration (FDA) has approved Foundayo (orforglipron) for adults with obesity, or overweight with weight-related medical problems.
When used alongside a reduced- calorie diet and increased physical activity, Foundayo helps individuals lose excess body weight and keep the weight off, it said.
Foundayo will be available via LillyDirect, with prescriptions accepted immediately and shipping beginning April 6, followed shortly after by broad availability through US retail pharmacies and telehealth providers.
“People living with obesity need treatment options that meet them where they are – and for many, a once-daily pill that can be taken with no food or water restrictions can offer them greater flexibility in how they approach their treatment,” said Deborah Horn, DO, director of the Center for Obesity Medicine at McGovern Medical School at UTHealth Houston. “With Foundayo, we now have an oral option that delivered an average of 12.4% weight loss at the highest dose in clinical trials – addressing both the clinical realities of obesity and the practical challenges patients face every day.”
Supported by the rigorous ATTAIN clinical trial programme, Foundayo was proven to help people lose weight and keep it off. 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. In the ATTAIN programme, 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, it said.
“Today, fewer than 1 in 10 people who could benefit from a GLP-1 are taking one, held back by access, stigma, perceived complexity or the belief that their condition isn’t serious enough for treatment. We believe Foundayo can help level the playing field for those living with obesity or who are overweight and living with weight-related complications,” said David A Ricks, chair and CEO of Eli Lilly and Company. “As a convenient, once-daily oral pill that delivers meaningful weight loss, this is obesity care designed for the real world.”
Eli Lilly said use of Foundayo with other GLP-1 receptor agonist medicines is not recommended. It is not known whether Foundayo is safe and effective for use in children. Foundayo may cause tumors in the thyroid, including thyroid cancer. Watch for possible symptoms, such as a lump or swelling in the neck, hoarseness, trouble swallowing or shortness of breath. If you have any of these symptoms, tell your health care provider.
The most common side effects of Foundayo include nausea, constipation, diarrhea, vomiting, indigestion, stomach (abdominal) pain, headache, swollen belly, feeling tired, belching, heartburn, gas, and hair loss. These are not all the possible side effects of Foundayo, it added.
“There is no single path that works for everyone living with overweight or obesity,” said Joe Nadglowski, president and CEO of the Obesity Action Coalition. “New treatment options expand choice and help more people find care that fits their lives, their goals and where they are in their journey – whether they’re just starting to explore treatment or looking for a different long-term approach.
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. - TradeArabia News Service
