Novo Nordisk Reports the Health Canada’s Approval of Ozempic to Reduce Risk of Kidney Disease Progression & Cardiovascular Death in T2D & CKD Adults

Shots: Health Canada has approved Ozempic to reduce the risk of kidney disease worsening & CV death in adults with type 2 diabetes (T2D) & chronic kidney disease (CKD) Approval was based on P-IIIb (FLOW) trial assessing Ozempic (1mg, Q1W, n=1767) vs PBO (n=1766) in type 2 diabetes & CKD pts (N=3533) Study met its 1EP of 24% relative…

ByRidhi Rastogi3 days ago

NEWS

Novo Nordisk Reports the US FDA’s Approval of Wegovy for Metabolic Dysfunction-Associated Steatohepatitis (MASH)

Shots: The US FDA has approved a label extension for Wegovy to treat noncirrhotic MASH in adults with mod. to adv. liver fibrosis (F2 to F3 fibrosis) in combination with a reduced calorie diet & increased physical activity; Application submitted to EMA & PMDA in Feb & May 2025, respectively Approval was based on Part…

ByRidhi RastogiAugust 18, 2025

NEWS

Novo Nordisk Reports the EMA’s Application Submission for Higher Wegovy Dose for Weight Management

Shots: The EMA has received an application for a higher dose of Wegovy (semaglutide 7.2mg, SC) to treat obesity Application was backed by the 72wk. STEP UP trial assessing Wegovy (7.2mg) vs Wegovy (2.4mg) & PBO alongside lifestyle intervention in 1,407 adults without diabetes (BMI ≥30kg/m²), & the 72wk. STEP UP T2D trial assessing Wegovy…

ByRidhi RastogiJuly 9, 2025

NEWS

Novo Nordisk Reveals P-III (REDEFINE 2) Trial data of CagriSema for Weight Loss in Obese/Overweight and T2D Patients

Shots: Novo Nordisk has reported P-III (REDEFINE 2) trial data assessing CagriSema (cagrilintide 2.4mg + semaglutide 2.4mg, QW, SC) vs PBO in 1,206 obese/overweight pts (~102Kg) and type 2 diabetes for 68wks., and followed flexible dosing protocol with 61.9% pts reaching highest dose after 68wks. Trial met its co-1EPs demonstrated 15.7% superior weight loss…

ByRidhi RastogiMarch 11, 2025

NEWS

Novo Nordisk Reports Headline Results from P-IIIb (STEP UP) Study of Semaglutide 7.2mg in Obese Adults without Diabetes

Shots: The P-IIIb (STEP UP) study assessed semaglutide (7.2mg) vs semaglutide (2.4mg) & PBO as an adjunct to lifestyle intervention in obese adults (n=1,407; BMI ≥30kg/m^2) without diabetes for 72wks. STEP program also includes STEP UP T2D study of semaglutide (7.2mg) in obese adults (n=512) with T2D for 72wks. Study met its 1EP, depicting…

ByRidhi RastogiJanuary 20, 2025

INSIGHTS+

Top Performing Drug – Ozempic (September Edition)

Shots: PharmaShots’ next episode on the top-performing drug of the month, based on 2021 revenue, focuses on Ozempic, a drug developed and marketed by Novo Nordisk Ozempic (semaglutide) is a human GLP-1 receptor agonist (or GLP-1 analog). It, when taken along with diet and exercise, is proven to improve blood sugar in adults with type 2…

BySenior EditorSeptember 27, 2023

Novo Nordisk Reports the Health Canada’s Approval of Ozempic to Reduce Risk of Kidney Disease Progression & Cardiovascular Death in T2D & CKD Adults

Novo Nordisk Reports the US FDA’s Approval of Wegovy for Metabolic Dysfunction-Associated Steatohepatitis (MASH)

Novo Nordisk Reports the EMA’s Application Submission for Higher Wegovy Dose for Weight Management

Novo Nordisk Reveals P-III (REDEFINE 2) Trial data of CagriSema for Weight Loss in Obese/Overweight and T2D Patients

Novo Nordisk Reports Headline Results from P-IIIb (STEP UP) Study of Semaglutide 7.2mg in Obese Adults without Diabetes

Top Performing Drug – Ozempic (September Edition)

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