The FDA has approved a second oral GLP-1 receptor agonist for weight loss in adults with obesity or overweight and weight-related comorbidities.
A once-daily tablet, orforglipron (Foundayo) is indicated in conjunction with a reduced-calorie diet and increased physical activity and can be taken at any time of day without restrictions on food and water intake — setting it apart from oral semaglutide (Wegovy), which needs to be taken with water in the morning on an empty stomach.
Green-lit within 50 days of filing, orforglipron marks the first approval of a new molecular entity under the FDA Commissioner’s National Priority Voucher pilot program — the quickest approval for a new drug since 2002, according to the agency.
Approval was supported by two phase III trials of over 4,500 participants that showed reductions in body weight as well as in waist circumference, non-HDL cholesterol, triglycerides, and systolic blood pressure.
After 72 weeks, patients treated at the highest orforglipron dose (36 mg) in the ATTAIN-1 and ATTAIN-2 trials lost 9.6% to 11.2% of their body weight on average — about 23-25 lb.
However, the highest approved dose of orforglipron is 17.2 mg, and the prescribing information indicates a maximum daily dosage of 17.2 mg. With a 12-mg pill in trials, average loss in body weight ranged from 7% to 8.4% at week 72.
By comparison, study participants in OASIS 4 averaged a 13.6% loss in body weight with the approved maximum dose of oral semaglutide, 25 mg.
The most common side effects of orforglipron are consistent with other GLP-1 medications, including nausea, constipation, diarrhea, vomiting, indigestion, stomach pain, headache, abdominal distension, fatigue, belching, heartburn, flatulence, and hair loss.
Like semaglutide and tirzepatide (Zepbound), orforglipron carries a boxed warning regarding the potential risk of thyroid C-cell tumors. It is also contraindicated in patients with a personal or family history of medullary thyroid carcinoma or in patients with multiple endocrine neoplasia syndrome type 2.
Additional warnings are listed for pancreatitis, severe gastrointestinal reactions, acute kidney injury due to volume depletion, hypoglycemia, hypersensitivity, diabetic retinopathy in patients with type 2 diabetes, acute gallbladder disease, and pulmonary aspiration during general anesthesia or deep sedation. Orforglipron should not be used in combination with other GLP-1 agents.
A cardiovascular outcomes study for orforglipron is underway, and the agent is also being studied as a potential treatment for type 2 diabetes, obstructive sleep apnea, osteoarthritis knee pain, hypertension, peripheral artery disease, and stress urinary incontinence.
Eli Lilly said the rollout of orforglipron will begin next Monday. In addition to retail pharmacies and telehealth providers, orforglipron will be available through LillyDirect starting at $25 per month with commercial coverage and $149 for cash-paying patients. Eligible Medicare Part D enrollees may be able to get it for $50 per month, beginning as soon as July.
Source link : https://www.medpagetoday.com/endocrinology/obesity/120601
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Publish date : 2026-04-01 20:15:00
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