Saudi Food and Drug Authority approves Foundayo for obesity treatment

The Saudi Food and Drug Authority has approved the registration of Foundayo for the treatment of obesity and overweight in adults, particularly those with at least one weight-related medical condition, following a comprehensive evaluation of its efficacy, safety, and quality.

The authority stated that the drug, which contains the active ingredient orforglipron, is used alongside a healthy diet and physical activity, and is administered orally once daily to support long-term weight loss and maintenance.

Clinical trial results

The authority explained that the approval was based on the results of two pivotal phase III studies conducted over 72 weeks. The first study involved 3,127 adults with obesity but without diabetes, and the highest dose of the drug (36 mg) led to an average weight reduction of 11.2% from baseline, compared to 2.1% in the placebo group.

The second study included 1,613 adults with obesity and type 2 diabetes, where a 36 mg dose of Foundayo resulted in an average weight reduction of 9.6%, compared to 2.5% in the placebo group.

Side effects and warnings

The authority also noted that the most common side effects included gastrointestinal issues such as nausea, constipation, diarrhea, vomiting, indigestion, abdominal pain, as well as bloating, hair loss, and fatigue. Most of these effects were mild to moderate in severity and typically occurred during dose escalation, decreasing over time.

The authority emphasized that the drug is contraindicated for patients with a personal or family history of certain types of thyroid tumors or related genetic syndromes, and should only be used under medical supervision with regular monitoring during treatment.

This approval reflects the authority's commitment to supporting modern therapeutic options and improving healthcare quality, in line with the goals of the Health Sector Transformation Program under Saudi Vision 2030.