Novartis announced Wednesday that Leqvio lowered bad cholesterol levels, compared with a placebo or the cholesterol-lowering drug ezetimibe, in patients at low-to-moderate risk of developing atherosclerotic heart disease.
In the Phase 3 V-Mono study, 350 patients were given either Leqvio, ezetimibe or placebo. Leqvio is an RNA therapy meant to lower cholesterol that’s dosed initially at three months, then given once every six months. Patients included in the study had high cholesterol but weren’t receiving any other lipid-lowering therapy.
Novartis didn’t share detailed results Wednesday, saying it will present them at an upcoming medical meeting. The company also plans to take the data to the FDA and other regulatory bodies.
Leqvio is approved by the FDA for people with a genetic high cholesterol condition called HeFH or those with atherosclerosis who need additional cholesterol-lowering on top of diet and statins. Novartis is studying the RNA therapy in several primary and secondary prevention studies in a bid to expand its use.
The Swiss pharma company licensed Leqvio from RNA biotech Alnylam. Leqvio is an RNA silencing therapy that targets PCSK9. Regeneron and Sanofi, as well as Amgen, also have PCSK9 treatments on the market. And Verve Therapeutics is developing a gene-editing approach to the cholesterol-lowering target, where Lilly has opt-in rights.
Leqvio generated $182 million in the second quarter of this year, more than double the second quarter of 2023.