The decision positions LANGLARA as only the fourth insulin glargine product available in the US market, joining established products commercialized by Novo Nordisk, Sanofi and Eli Lilly.
The study showed that oral semaglutide achieved a significantly greater reduction in HbA1c levels, a key marker of blood sugar control, compared to placebo.
The approval specifically applies to adults diagnosed with obesity and does not extend to individuals who are overweight with a BMI below 30kg/m² using Wegovy for weight management.
The collaboration leverages JW Pharmaceutical’s established research and development capabilities to accelerate the drug’s entry into South Korea’s growing metabolic disease sector.
Foundayo (orforglipron) is the first once-daily oral GLP-1 approved for weight management with no restrictions on food, water, or timing.
When combined with a reduced-calorie diet and regular physical activity, Foundayo helps patients shed excess weight and maintain their progress.
The drug works as a once-daily glucagon-like peptide-1 (GLP-1) receptor agonist, requiring no food or water restrictions before taking it.
A central focus of the partnership is equipping family physicians and other healthcare professionals to better identify and support individuals at risk.
Awiqli® changes that by offering a single weekly dose, giving patients greater flexibility to fit treatment into their individual lifestyles and preferences.
Wegovy HD became the fourth drug to receive FDA approval through the Commissioner’s National Priority Voucher pilot programme.