Novartis Heart Drug Fails Major Trial, Raising Questions Over Lp(a) Treatment
Pelacarsen lowered genetically linked cholesterol levels but did not reduce heart attacks and strokes in a large late-stage study, dealing a setback to efforts targeting lipoprotein(a).
New DElhi, Sep 05 : Novartis and Ionis Pharmaceuticals have suffered a setback after their experimental heart drug pelacarsen failed to meet the main goal of a large late-stage clinical trial.
The drug was being developed to reduce the risk of major cardiovascular events by lowering levels of lipoprotein(a), or Lp(a), a largely inherited form of cholesterol associated with an increased risk of heart disease and stroke.
The trial enrolled more than 8,000 participants and followed them for more than six years. Although pelacarsen successfully reduced Lp(a) levels, the treatment did not produce a statistically significant reduction in major heart attacks and strokes, according to Novartis.
The outcome raises questions about whether lowering Lp(a) alone is sufficient to deliver meaningful cardiovascular benefits. Several pharmaceutical companies are developing medicines aimed at the same biological target, making the findings particularly significant for the wider drug-development field.
The setback also comes at an important point for Novartis as the Swiss pharmaceutical company works to strengthen its pipeline ahead of expected pressure from patent expirations and declining revenue from some established medicines.
Novartis shares fell about 5%, while Ionis shares dropped around 12% in after-hours trading following the announcement.
The companies are expected to present detailed results from the study at an upcoming medical congress. Researchers and investors will examine the full data to better understand why the substantial reduction in Lp(a) did not translate into the expected cardiovascular protection.
The results could also influence the development strategies of other drugmakers pursuing Lp(a)-lowering therapies, including Amgen and Eli Lilly.
