Novartis announced that the US FDA approved Leqvio (inclisiran) to decrease the lower low-density lipoprotein cholesterol (bad cholesterol) in the blood. Leqvio is a small interfering RNA (siRNA) therapy, administered two years after the initial treatment and the second after three months. The drug is approved for lowering bad cholesterol in patients with atherosclerotic cardiovascular disease (ASCVD) or heterozygous familial hypercholesterolemia (HeFH).
The approval is based on Phase III ORION-9, -10, and -11 clinical trials, which enrolled 3,457 patients. Patients were also administered with maximum tolerated statin therapy. In the trials, Leqvio decreased the LDL-C levels significantly (52%) compared to placebo with a good safety profile.
The company announced that the product would be available from early January 2022.
RNAi therapy company Alnylam Pharmaceuticals designed inclisiran, and The Medicines Company struck a deal to develop, license, and commercialize the drug. In early 2020, Novartis has acquired The Medicines Company along with inclisiran.
Inclisiran acts by inhibiting the production of the PCSK9 enzyme in the liver. There are two other PCSK9 inhibitors available - Regeneron's Pralulent and Amgen's Repatha. Both the drugs were unable to make $1 billion in annual sales. The drug is expected to have peak sales of $2 billion by 2026.