FDA Approves FOUNDAYO (orforglipron) for chronic weight management in adults with obesity or overweight with comorbidities.

FOUNDAYO is a GLP-1 receptor agonist.

FOUNDAYO is indicated 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. Limitations of Use: Concomitant use with another GLP-1 receptor agonist is not recommended.

Take FOUNDAYO orally once daily, with or without food. Swallow tablets whole; do not break, crush, or chew. Do not take more than one tablet per day. Starting dosage is 0.8 mg once daily. After at least 30 days, increase to 2.5 mg once daily. After at least 30 days on 2.5 mg, increase to 5.5 mg once daily. Dosage may be increased to the next level (9 mg, 14.5 mg, or 17.2 mg once daily) after at least 30 days on the current dosage, based on treatment response and tolerability. Maximum dosage is 17.2 mg once daily. For drug interactions: Avoid strong CYP3A4 inhibitors that also inhibit OATP1B; maximum dosage is 9 mg once daily if used concomitantly with a strong CYP3A4 inhibitor. Avoid strong CYP3A4 inducers. Monitor effectiveness with moderate CYP3A4 inducers and escalate dosage as needed. If a dose is missed, take as soon as possible; do not double the next dose. If 7 or more consecutive doses are missed, reinitiate dosage escalation at a lower dosage.

The effectiveness of FOUNDAYO was established in two randomized, double-blind, placebo-controlled trials (Trials 1 and 2) of an investigational orforglipron formulation, shown as equivalent dosages of once-daily FOUNDAYO. Both trials were 72 weeks in duration and enrolled adults aged 18 years and older with obesity (BMI ≥30 kg/m2) or overweight (BMI 27 to <30 kg/m2) with at least one weight-related comorbid condition (e.g., dyslipidemia, hypertension, obstructive sleep apnea, cardiovascular disease); patients with type 2 diabetes were excluded. All patients received standard lifestyle intervention (reduced-calorie diet and physical activity counseling). In Trial 1 (NCT05869903, N=3,127), patients were randomized to FOUNDAYO 5.5 mg, 9 mg, 17.2 mg, or placebo once daily. Baseline characteristics: mean age 45 years, 64% female, mean body weight 103.2 kg, mean BMI 37 kg/m2. The primary efficacy parameter was mean percent change in body weight after 72 weeks of treatment. Trial 2 design was similar with a different randomization ratio.

Not reported in label.

FOUNDAYO is an oral GLP-1 receptor agonist approved for chronic weight management in conjunction with lifestyle modification in adults with obesity or overweight with comorbidities. The label specifies it should not be used concomitantly with another GLP-1 receptor agonist.