By Fineline Cube 
Novo Nordisk (NYSE: NVO) announced that the U.S. Food and Drug Administration (FDA) has granted a new indication for Rybelsus, the company’s oral GLP‑1 agonist semaglutide. The approval expands Rybelsus 7 mg and 14 mg dosage forms to lower the risk of major adverse cardiovascular events (MACE) — including cardiovascular death, heart attack, and stroke — in adults with type 2 diabetes who are at high cardiovascular risk, irrespective of prior events.
Key Highlights
- First Oral GLP‑1 Therapy – Rybelsus remains the only oral GLP‑1 agonist available worldwide.
- Expanded Indication – Both 7 mg and 14 mg tablets now authorized for primary and secondary cardiovascular prevention in type 2 diabetes.
- Clinical Proof – Data from the Phase III SOUL trial showed a 14 % relative risk reduction in MACE with 14 mg Rybelsus versus placebo, on top of standard care.
- Market Position – Rybelsus first approved in 2019 for glycaemic control; elevated to a first‑line option in 2023.
Implications for Patients and Clinicians
- Broadening Therapeutic Options – Enables clinicians to prescribe an oral, once‑daily medication that addresses both glucose control and cardiovascular risk.
- High‑Risk Population Coverage – The indication applies to patients with or without prior cardiovascular events, addressing a large unmet need.
- Patient Adherence – Oral formulation may improve adherence compared to injectables, potentially translating into better real‑world outcomes.
Forward‑Looking Statements
This release contains forward‑looking statements that involve risks and uncertainties. Actual results may differ materially.-Fineline Info & Tech