On Sept. 4, Novartis announced that its experimental drug to prevent heart attack, strokes and cardiovascular death, pelacarsen, had failed.
“Lp(a)HORIZON was a pioneering cardiovascular outcomes trial designed to answer one of the most important unanswered questions in cardiovascular medicine by evaluating whether lowering Lp(a) can reduce residual cardiovascular risk beyond optimized, guideline-directed care, when other major cardiovascular risk factors are already being managed,” Shreeram Aradhye, president of development and chief medical officer at Novartis, said in a Sept. 4 news release. “Although lower Lp(a) levels were observed with pelacarsen, the findings did not demonstrate that this translated into reduced cardiovascular risk in the overall study population. These are not the results we hoped for, but they provide important evidence that advances scientific understanding of the relationship between Lp(a) lowering and cardiovascular outcomes and may help inform future approaches to cardiovascular risk management.”
Here is what to know.
1. Pelacarsen was designed to block a protein called lipoprotein(a) that is a risk factor for heart disease. One in five people have elevated Lp(a) levels, and people with the highest levels — above 250 milligrams per deciliter of blood — had double the risk for a heart attack or stroke. Lp(a) levels are largely determined by genes and do not fluctuate throughout life or are impacted by lifestyle changes.
2. In an earlier study, Novartis’ drug reduced Lp(a) levels by 80%.
3. The most recent trial lasted seven years and involved more than 8,300 people with high Lp(a) levels and pre-existing heart disease. Participants injected the drug or a placebo once a month with a pre-filled syringe. Currently, Novartis has only reported the failure in accordance with federal regulations. The complete data set will be presented in November at the American Heart Association annual meeting, The New York Times said.
4. Amgen and Eli Lilly have similar drugs in large clinical trials, providing some hope for the Lp(a) lowering hypothesis, the Times said.
5. Novartis’ announcement comes almost a month after Novo Nordisk’s ziltivekimab drug, meant to reduce inflammation, also failed.
At the Becker's 11th Annual IT + Revenue Cycle Conference: The Future of AI & Digital Health, taking place September 14–17 in Chicago, healthcare executives and digital leaders from across the country will come together to explore how AI, interoperability, cybersecurity, and revenue cycle innovation are transforming care delivery, strengthening financial performance, and driving the next era of digital health. Apply for complimentary registration now.
