SFDA approves first daily oral weight-loss drug for adults with obesity

According to the Saudi Gazette, the Saudi Food and Drug Authority (SFDA) has officially approved the registration of Foundaio, a new once-daily oral medication designed to assist in long-term weight management. The drug is indicated for adults struggling with obesity or those who are overweight and possess at least one weight-related health condition. The treatment is intended to be used in conjunction with a structured healthy diet and regular physical activity.

The active ingredient in the medication is orforglipron, which functions by activating glucagon-like peptide-1 (GLP-1) receptors. By targeting these receptors, the drug helps regulate appetite and blood sugar levels, which in turn reduces overall food intake and supports sustained weight loss. The SFDA noted that this oral administration offers a distinct alternative to other GLP-1 therapies that may require different delivery methods.

The regulatory approval follows a rigorous assessment process conducted by the SFDA, which evaluated the drug's safety, efficacy, and quality standards. This decision was supported by data from two pivotal Phase 3 clinical trials that spanned 72 weeks. The first of these trials involved a cohort of 3,127 adults with obesity who did not have a diagnosis of diabetes, providing a significant evidence base for the medication's performance in a clinical setting.

This approval marks a notable development in the pharmaceutical landscape within the Kingdom, providing patients with a new tool to manage obesity-related health risks. As with all prescription medications, the SFDA emphasizes that the drug should be used under the guidance of healthcare professionals to ensure it is appropriate for an individual's specific medical history and health needs.