Novo Nordisk's Ozempic Label Expansion Snags Approval From European Drug Regulator's Advisory Panel

On Thursday, the European Medicines Agency’s Committee for Medicinal Products for Human Use adopted a positive opinion for an update for Novo Nordisk A/S’ NVO Ozempic (once-weekly subcutaneous semaglutide) label to reflect data from the FLOW kidney outcomes trial.

The FLOW trial assessed the risk reduction from Ozempic therapy in chronic kidney disease-related events.

Also Read: Want To Bet On Ozempic, Wegovy Success? Defiance Introduces Leveraged ETF To Capture Novo Nordisk Momentum

In the FLOW trial, semaglutide 1.0 mg demonstrated a statistically significant and superior 24% risk reduction in kidney disease progression, cardiovascular disease, and kidney death compared to placebo.

The combined primary endpoint included five components measuring the progression of CKD and the risk of kidney and cardiovascular mortality. 

In addition, the secondary endpoints in the trial showed that the risk of major cardiovascular events was reduced by 18%, and the risk of all-cause mortality was reduced by 20%.

Novo Nordisk has also filed for a label expansion in the US, and a decision is expected in the first half of 2025.

Last week, GoodRx Holdings GDRX, a prescription savings platform in the U.S., released its latest Weight Loss Medications Tracker, revealing a sharp increase in the use of popular weight loss drugs like Eli Lilly And Co’s LLY Mounjaro and Zepbound as well as Novo Nordisk’s Ozempic and Wegovy.

Despite limited insurance coverage and high out-of-pocket costs, demand for these medications is soaring.

Price Action: NVO stock is down 1.8% at $109.68 at last check Thursday.

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