An Endocrine News roundup of the week’s pharmaceutical news, breakthroughs, and general information. *
FDA Approves Lilly’s Foundayo™ Weight Loss GLP-1 Pill
On April 1, Eli Lilly and Company announced that the U.S. Food and Drug Administration (FDA) 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. Foundayo will be available via LillyDirect®, with prescriptions accepted immediately and shipping beginning April 6, followed shortly after by broad availability through U.S. 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 program, 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.1 Participants taking Foundayo, regardless of trial completion, lost an average of 25 pounds (11.1%), compared to 5.3 pounds (2.1%) with placebo.2 In the ATTAIN program, 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.
“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.”
Lilly is committed to making Foundayo accessible and affordable. Eligible people with commercial insurance may pay as little as $25 per month with the Foundayo savings card.3 Individuals opting for self-pay can access Foundayo starting at $149 per month for the lowest dose. Additionally, eligible Medicare Part D individuals may be able to get Foundayo for $50 per month, beginning as soon as July 1, 2026.
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. Please see Indication and Safety Summary with Warning below and full Prescribing Information and Medication Guide.
“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.
For more information about Foundayo, please visit www.foundayo.lilly.com.
Viridian Announces Positive Topline Results in TED Clinical Trial
On March 30, Viridian Therapeutics, Inc., announced positive topline data from the elegrobart REVEAL-1 phase 3 clinical trial in patients with active thyroid eye disease (TED).
Viridian Therapeutics, Inc., is a biotechnology company focused on discovering, developing, and commercializing potentially best-in-class medicines for serious and rare diseases. Elegrobart is a subcutaneously delivered, half-life-extended monoclonal antibody targeting the insulin-like growth factor-1 receptor (IGF-1R). REVEAL-1 evaluated two dosing regimens, every four weeks (Q4W) and every eight weeks (Q8W), compared with placebo.
“We are excited to report these results from REVEAL-1, the largest pivotal clinical trial conducted in active TED to date, which position elegrobart as potentially the first ever subcutaneous autoinjector treatment for TED,” said Steve Mahoney, president and CEO of Viridian Therapeutics. “REVEAL-1 met its primary endpoint with high statistical significance. Elegrobart treatment drove robust proptosis responses in a treatment regimen comprised of as few as three subcutaneous doses. Further, in the Q4W arm, we saw clinically meaningful diplopia responses and diplopia resolution. Currently, the only marketed treatment for TED requires eight intravenous infusions and, despite low market penetration, annualized in 2025 to approximately $2B in revenues. We believe there is a significant opportunity with subcutaneous elegrobart in TED, including the potential to expand the market as an at-home and self-administered treatment option, if approved.”
“Subcutaneous elegrobart showed rapid and clinically meaningful reductions in proptosis and diplopia in REVEAL-1 with a highly convenient, well-tolerated dosing profile,” said Prem Subramanian, MD, PhD, professor of ophthalmology at Colorado University Anschutz, and chief of neuro-ophthalmology at the Sue Anschutz-Rodgers Eye Center. “Patients are seeking more treatment choices for TED, and there remains a clear need for a more conveniently administered therapy. I am very encouraged to see the data for elegrobart and believe it has the potential to reach more TED patients than an intravenous therapy and to provide them with an attractive treatment option.”
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