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Novartis reports first major clinical setback in race to develop targeted treatments for lipoprotein(a) cholesterol.

Novartis reported on Friday that its pelacarsen drug, developed jointly with Ionis Pharmaceuticals, failed to significantly improve cardiovascular outcomes in a late-stage clinical trial. While the drug successfully reduced a harmful form of cholesterol known as Lp(a), it did not provide the expected improvement in heart attacks and strokes.

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Lp(a) is a genetic condition that affects roughly one in five people worldwide and currently has no approved targeted treatment. The trial involved more than 8,000 patients who were already receiving optimized care. Novartis stated that the results provide evidence to advance scientific understanding of the relationship between Lp(a) lowering and cardiovascular risk. The failure of pelacarsen creates uncertainty for the pharmaceutical industry. Rival drugs from Amgen and Eli Lilly are currently being tested. Amgen's olpasiran faces a direct comparison to pelacarsen, while Eli Lilly's lepodisiran is being tested on a broader group of patients. The results of the trial may impact the market for Lp(a) treatments, which was expected to be worth billions of dollars.

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