The FDA approved Foundayo (orforglipron) oral tablets for use in combination with a reduced-calorie diet and increased physical activity to reduce excess body weight and maintain weight reduction long term in adults with obesity or adults with overweight in the presence of at least one weight-related comorbid condition.
Foundayo is a glucagon-like peptide-1 (GLP-1) receptor agonist in tablet form that should be taken orally once daily. Starting dosage is 0.8 mg, which should be increased to 2.5 mg after at least 30 days and then to 5.5 mg after another 30 days. The dosage may be increased further to 9 mg, 14.5 mg, or 17.2 mg after at least 30 days at each level based on treatment response and tolerability.
Two randomized, double-blind, placebo-controlled trials in adults with obesity or with overweight and one or more weight-related comorbidities supported the approval of Foundayo. In these trials, 72 weeks of treatment with Foundayo, in combination with a reduced calorie diet and increased physical activity, resulted in a statistically significant and clinically meaningful reduction in body weight in the Foundayo treated groups compared with the placebo group.
Foundayo can cause side effects such as nausea, constipation, diarrhea, vomiting, dyspepsia (pain, burning, or bloating of the stomach), headache, abdominal extension, fatigue, burping, gastroesophageal reflux disease, gas, and hair loss.
Foundayo also contains warnings and precautions for inflammation of the pancreas (pancreatitis), severe gastrointestinal reactions, acute kidney injury due to volume depletion, hypoglycemia (blood sugar that is too low), hypersensitivity, diabetic retinopathy (damage to the eye’s retina) in patients with type 2 diabetes mellitus, acute gallbladder disease, and pulmonary aspiration during general anesthesia or deep sedation. This drug should not be used in combination with another GLP-1 receptor agonist.
The labeling for Foundayo includes a boxed warning for thyroid C-cell tumors. Foundayo should not be used in patients with a personal or family history of medullary thyroid cancer or in patients with Multiple Endocrine Neoplasia syndrome type 2.
Of note, Foundayo was approved under the Commissioner's National Priority Voucher (CNPV) pilot program. Issued 50 days after filing, and 294 days before the application’s PDUFA date of January 20, 2027, this decision represents a historic milestone as the first new molecular entity (NME) approved under the program. It is also the fastest approval of an NME since 2002.
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