Novo Nordisk: Advances in Oral Semaglutide Therapy for Cardiovascular Diseases

Novo Nordisk has published the key results from their SOUL Phase 3 study on cardiovascular outcomes. The study investigated the efficacy of oral semaglutide as an adjunct therapy to standard care for preventing major adverse cardiovascular events (MACE). Last year, the subcutaneous weekly injection of semaglutide, known as Wegovy, already demonstrated an impressive 20 percent reduction in MACE compared to placebos. The current SOUL study follows a similar approach, but in oral form, and includes a total of 9,650 individuals with type 2 diabetes and existing cardiovascular or chronic kidney diseases. The results show that oral semaglutide, when taken daily, leads to a significant reduction in MACE by 14 percent compared to placebos. Primary endpoints such as heart attack, stroke, and cardiovascular death equally contributed to this impressive outcome. Novo Nordisk plans to apply for the market authorization expansion for Rybelsus in the USA and the EU by the end of 2024 or early 2025, after the detailed results of the SOUL study are presented at a scientific conference in 2025. In 2023, Rybelsus generated worldwide revenues of 18.75 billion DKK (approximately 2.73 billion USD). Currently, Novo Nordisk's stock is slightly weakened with a decline of 0.41 percent to 117.60 USD in pre-market trading.