Novartis Shares Fall as Experimental Heart Drug Fails in Late-Stage Study

Novartis AG (NVS) shares fell by more than 3% on Monday after the pharmaceutical giant announced on Friday that its experimental drug pelacarsen failed to achieve its main goal in a major late-stage clinical trial.

Trial Fails to Meet Primary Endpoint

The Lp(a)HORIZON study, which enrolled over 8,000 patients, was designed to see if pelacarsen could reduce the risk of major adverse cardiovascular events like heart attacks and strokes. The drug targets high levels of lipoprotein(a), or Lp(a), a type of blood fat genetically linked to an increased risk of heart disease.

According to Novartis, the trial did not meet its primary endpoint. While pelacarsen was successful in lowering Lp(a) levels in patients, this reduction did not translate into a statistically significant decrease in serious cardiovascular events.

A Setback for Cardiovascular Pipeline

The outcome represents a significant setback for Novartis's cardiovascular drug pipeline and casts doubt on the therapeutic strategy of targeting Lp(a) to prevent heart disease. Currently, no approved drugs specifically target this blood fat, which is estimated to affect approximately one in five people globally.

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The failure also has potential implications for competitors developing similar Lp(a)-lowering treatments, including Amgen and Eli Lilly. The results call into question whether simply reducing Lp(a) levels is sufficient to improve patient outcomes.

Company Response

“These are not the results we hoped for,” said Shreeram Aradhye, Novartis’s chief medical officer, in a statement. He added that the data still “advances scientific understanding of the relationship between Lp(a) lowering and cardiovascular outcomes.”

Novartis stated that the full results from the Lp(a)HORIZON trial will be presented at an upcoming medical congress.