July 31 (Reuters) – Novo Nordisk said on Friday its experimental drug failed to reduce the risk of major cardiovascular events compared with a placebo in a late-stage trial involving patients with heart disease, chronic kidney disease and inflammation.
Shares of the Danish drugmaker were down roughly 7% at 308 Danish crowns.
The disappointing data is a setback to Novo’s efforts to diversify its portfolio beyond its blockbuster weight-loss and diabetes treatments, Wegovy and Ozempic, and could limit its long-term revenue growth.
According to J.P. Morgan analysts, ziltivekimab’s failure “removes a potential multibillion-dollar asset from Novo’s pipeline.”
The results also deal a blow to broader efforts to target arterial inflammation to prevent cardiovascular disease.
Novo said the trial failed to show that ziltivekimab reduced the risk of major adverse cardiovascular events (MACE), which include death, non-fatal heart attack and non-fatal stroke, when compared with a placebo.
The study enrolled more than 6,300 patients to evaluate whether a once-monthly injection of ziltivekimab, a monoclonal antibody targeting the inflammatory protein IL-6 ligand, could lower the risk of those events.
Novo gained access to ziltivekimab through its $725 million buy-out of AstraZeneca spin-off Corvidia Therapeutics in 2020. At the time, the company said it expected the treatment to reach the market in the second half of this decade.
The trial failed to meet the minimum threshold of a 15% relative risk reduction in MACE, a level analysts said was necessary to support the drug’s future commercial and regulatory prospects.
Meanwhile, overall rates of side effects and serious adverse events were similar between the ziltivekimab and placebo groups, though serious infections were more common with ziltivekimab, consistent with IL-6-targeting therapies, Novo said.
In 2018, Novartis’ anti-inflammatory drug canakinumab was rejected by the U.S. Food and Drug Administration after clinical trials showed it reduced major cardiovascular events by about 15% but also doubled the risk of fatal infections, a trade-off regulators deemed unacceptable for preventive treatment.
Novo said the trial outcome will not affect its adjusted operating profit outlook for 2026, but it will lead to a non-cash impairment charge in the third quarter. It also said two ongoing trials of ziltivekimab, one in people with heart failure and another in people following an acute heart attack, will go on with results expected in the first half of 2027.
(Reporting by Siddhi Mahatole and Sneha S K in Bengaluru Bhanvi Satija in London and Boleslaw Lasocki; Editing by Diti Pujara)
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