Ozempic Gains First Approval In Canada For Kidney Disease And Cardiovascular Death Risk

Health Canada on Tuesday approved Novo Nordisk's NVO Ozempic (semaglutide) to reduce the risk of kidney disease and cardiovascular deaths in adults with type 2 diabetes.

The approval makes Ozempic the first once-weekly treatment for type 2 diabetes that not only improves glycemic control but also lowers the risk of eGFR decline, end-stage kidney disease, and cardiovascular death.

Results from the FLOW trial support the decision.

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The FLOW trial tested semaglutide's kidney-protective effects in patients with type 2 diabetes and CKD, enrolling more than 3,500 participants across 28 countries, including Canada.

The study met its primary endpoint. Semaglutide 1 mg cuts the risk of kidney disease progression and cardiovascular or kidney mortality by 24%. Compare that to the placebo (331 vs. 410 events). Initiated in 2019, the trial was halted early after an independent committee recommended discontinuation due to efficacy concerns.

Separately, the FDA recently granted an additional approval for Novo Nordisk's Wegovy (semaglutide 2.4 mg) to treat noncirrhotic metabolic dysfunction-associated steatohepatitis (MASH) in adults with moderate to advanced liver fibrosis, based on positive results from the ESSENCE trial.

In pricing news, GoodRx GDRX announced a partnership with Novo Nordisk making Ozempic and Wegovy pens available to eligible self-paying patients for $499 per month. Nearly 17 million people visited GoodRx last year for GLP-1 savings and information, a 22% increase from 2023.

Price Action: Novo Nordisk stock is up 1.1% at $54.34 at the last check on Tuesday.

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