ACC: New owner Novartis presents pooled inclisiran data cutting LDL cholesterol by half

Novartis headquarters
Novartis' inclisiran is currently being reviewed by the FDA and the European Medicines Agency for use against atherosclerotic cardiovascular disease and an inherited disorder that causes high cholesterol. (Novartis)

A new analysis of the cholesterol-lowering inclisiran could add some juice to the PCSK9 drug—which Novartis picked up in its $9.7 billion purchase of The Medicines Company last year—showing it was able to cut LDL levels by 51% after nearly a year and a half.

The data, pooled from three previously successful phase 3 studies in people with high cholesterol, were presented at the virtual scientific meeting of the American College of Cardiology, held online together with the World Congress of Cardiology.

Inclisiran posted durable reductions in LDL cholesterol when used with other lipid-lowering therapies over 17 months. In addition, a preliminary safety analysis noted fewer major cardiac side effects and nonfatal heart attacks compared with placebo, according to Novartis, while overall safety was similar.

“There remains a compelling need for new and novel LDL-C-lowering therapies given the residual risk faced by many patients with atherosclerotic cardiovascular disease and the inability of oral lipid-lowering therapy alone to achieve important LDL targets,” said R. Scott Wright, principal investigator of one of inclisiran’s phase 3 studies and a professor of medicine at the Mayo Clinic.

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Inclisiran consists of double-stranded, small interfering RNA that hinder the expression of specific genes. It’s given as an injection every six months, compared to monthly or every two weeks with other approved PCSK9 drugs such as Amgen’s Repatha or Sanofi and Regeneron’s Praluent.

The drug is currently being reviewed by the FDA and the European Medicines Agency for use against atherosclerotic cardiovascular disease and an inherited disorder that causes high cholesterol, including in patients that have already maxed out the doses of other therapies.

“Inclisiran harnesses the body’s natural mechanisms for RNA silencing and lowers LDL-C,” Wright said. “This analysis confirms that twice-yearly dosing of inclisiran achieves durable and potent reductions in LDL-C in the phase III studies.”

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A fourth phase 3 study, set to recruit 15,000 participants in the U.S. and the U.K., is currently exploring the drug’s long-term cardiovascular outcomes through 2024.

Previously, EvaluatePharma’s researchers estimated that inclisiran sales could reach $1.529 billion by that time, but analysts would prefer to see that number top at least $2 billion annually to justify Novartis’ $9.7 billion purchase price.