FDA Approves Orforglipron Under CNPV

The FDA announced the approval of Foundayo (orforglipron), the first new molecular entity approved through the Commissioner’s National Priority Voucher (CNPV) pilot program.

The FDA indicated Foundayo is approved for long-term reduction and maintenance of weight reduction in adults with obesity, or adults with overweight who have at least one weight-related comorbid condition, used with a reduced-calorie diet and increased physical activity. The agency cited two randomized, double-blind, placebo-controlled trials in these populations as the basis for approval. Across the trials, 72 weeks of treatment with Foundayo was associated with a statistically significant reduction in body weight compared with placebo.

Foundayo is an oral glucagon-like peptide-1 receptor agonist tablet taken once daily, with dosing that begins at 0.8 mg and may be escalated to 2.5 mg after at least 30 days and to 5.5 mg after another 30 days. The labeling also notes optional further increases to 9 mg, 14.5 mg, or 17.2 mg after at least 30 days at each level based on treatment response and tolerability.

Common adverse reactions include nausea, constipation, diarrhea, vomiting, dyspepsia, abdominal pain, headache, abdominal distension, fatigue, burping, gastroesophageal reflux disease, gas, and hair loss. The labeling includes a boxed warning for thyroid C-cell tumors and additional warnings and precautions, and it stated the product should not be used with another GLP-1 receptor agonist.