Ozempic Cuts Kidney Risk By 24%
Executive Summary
But Novo’s blockbuster lags established drugs in diabetic kidney disease patients, and will probably be regarded as an adjunct.
The headline 24% cut in the risk of kidney disease-related events with Ozempic (semaglutide) in the FLOW study revealed today is not unimpressive, and puts Novo Nordisk A/S’s cash cow ahead of its rival incretin, Eli Lilly and Company’s Mounjaro.
Key Takeaways
- Novo Nordisk’s Ozempic cut the risk of kidney disease events by 24% over placebo in the FLOW kidney outcomes trial
- This effect is not as strong as with the two main SGLT2 inhibitors
- Ozempic could be relegated to use as an add-on therapy
That said, it falls some way behind therapies that are already widely used in this population. The SGLT2 inhibitors sold by Lilly and AstraZeneca PLC look better than Ozempic on a cross-trial basis, and Novo will have to hope Ozempic can find a niche as an add-on therapy.
The Phase III trial, testing Ozempic in more than 3,500 patients with both type 2 diabetes and chronic kidney disease, was stopped almost a year early thanks to clear signs of efficacy last October. It tested the GLP-1 agonist on top of standard of care for prevention of progression of kidney impairment and risk of kidney and cardiovascular mortality in people with type 2 diabetes and chronic kidney disease (CKD). (Also see "The FLOW Of Novo Nordisk's Semaglutide Success Rolls Into Kidney Disease" - Scrip, 11 Oct, 2023.)
Today, the Danish group disclosed the magnitude of the hit: Ozempic achieved a 24% cut in a composite of kidney disease progression, major adverse cardiovascular events and death, versus placebo. The result was both statistically significant and superior.
Both kidney disease and cardiovascular components of the primary endpoint contributed to the risk reduction, Novo said. It added that the superiority of Ozempic over placebo was seen for secondary endpoints too, though it did not offer specifics.
Safety was in line with other trials of the drug, the group said, suggesting that manageable gastrointestinal effects were the main events seen.
Novo Nordisk plans to file for a label expansion in the US and EU this year. Adding CKD risk reduction to Ozempic’s label, along with the cardiovascular risk reduction claim it already carries, ought to allow the group to get the jump on Lilly. The US major’s rival product Mounjaro (tirzepatide) is in a Phase II study, TREASURE-CKD, in overweight or obese patients with CKD, with or without type 2 diabetes.
Stake In Kidney
But Mounjaro might not be the real competition in this setting. The two blockbuster SGLT2 inhibitors – Lilly’s Jardiance (empagliflozin) and AstraZeneca’s Farxiga (dapagliflozin) – are widely used to guard against kidney events in adults with CKD who are at risk of progression, whether co-morbid with type 2 diabetes or not.
In the comparable trials of these two agents, Jardiance’s EMPA-KIDNEY and Farxiga’s DAPA-CKD, 46% and 68% of patients had diabetes, respectively. In these diabetic patients specifically, both drugs demonstrated a greater reduction in kidney event risk than Ozempic managed.
It should be noted that the primary efficacy endpoints of the three trials were slightly different, though roughly comparable. Both EMPA-KIDNEY and DAPA-CKD were, like FLOW, stopped early for efficacy.
The anticlimactic nature of the 24% figure is underlined by a small rally by dialysis technology companies. Stock in Fresenius Medical Care AG & Co. KGaA and DaVita Labs was up 11% and 7%, respectively, in early trade.
Though the SGLT2 inhibitors have outplayed Ozempic here, it is not necessarily a case of either-or: GLP-1 inhibition can be added to SGLT2 blockade, should a doctor believe a patient would benefit from the combo. Even so, the commercial implications of the FLOW data could be modest, since there are probably few physicians in need of more reason to prescribe a GLP-1 to a patient with diabetes plus a comorbidity like CKD.