Saudi Food and Drug Authority approves obesity drug Fawandio

The Saudi Food and Drug Authority (SFDA) has granted registration for the oral medication Fawandio, containing the active ingredient orforglipron, to treat obesity and excess weight in adults, particularly those with at least one weight‑related health condition. The approval follows a comprehensive review of efficacy, safety and quality data from two pivotal phase‑3 trials lasting 72 weeks.

In the first trial of 3,127 non‑diabetic adults, the highest dose (36 mg) produced an average weight loss of 11.2 % of baseline weight versus 2.1 % with placebo. In the second trial of 1,613 adults with type‑2 diabetes, the same dose yielded a 9.6 % reduction versus 2.5 % for placebo. Common adverse events were mild to moderate gastrointestinal symptoms, abdominal bloating, hair loss and fatigue, typically occurring during dose escalation and diminishing over time. The SFDA cautions against use in patients with personal or family histories of certain thyroid tumors or related genetic syndromes and requires medical supervision with regular monitoring. The decision aligns with Saudi Arabia’s Vision 2030 health‑sector transformation goals.