Novo Nordisk A/S Sponsored ADR Class B (NVO.US) has applied for a listing of its new indication for semaglutide in China.
Novo Nordisk (NVO.US) files for new indication for Semaglutide.
On March 3, the CDE website showed that Novo Nordisk A/S Sponsored ADR Class B (NVO.US) applied for a new indication for semaglutide. Based on the progress of clinical trials and regulatory filings, it is speculated that the indication for this application is metabolic dysfunction-associated fatty liver disease (MAFLD).
It is reported that as of now, semaglutide has been approved for 4 indications in China, including: for assisting diet and exercise to improve blood sugar control in patients with type 2 diabetes (T2DM); for long-term weight management in adults who are overweight (initial BMI 27kg/m2 and <30kg/m2) or obese (initial BMI 30kg/m2) and have at least one weight-related complication, on the basis of controlling diet and increasing physical activity; for lowering the risk of eGFR decline, end-stage renal disease, and cardiovascular death in T2DM adult patients with chronic kidney disease; for reducing the risk of major adverse cardiovascular events (cardiovascular death, non-fatal myocardial infarction, non-fatal stroke) in adult patients diagnosed with cardiovascular disease and with a BMI 27kg/m2.
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