FDA approves inclisiran for LDL lowering
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Novartis announced the FDA approved inclisiran, its small-interfering RNA therapy for LDL lowering.
After an initial dose and one at 3 months, inclisiran (Leqvio) is administered twice per year as a subcutaneous injection, according to a press release issued by the company.
The drug was approved as an adjunct to diet and maximally tolerated statin therapy for adults with clinical atherosclerotic CVD or heterozygous familial hypercholesterolemia who require additional LDL lowering, the company stated in the release.
Approval was based on the ORION-9, ORION-10 and ORION-11 phase 3 trials, which demonstrated inclisiran reduced LDL by up to an additional 52% in the patient population for which the drug is now indicated, with a safety profile comparable to placebo, according to the release.
“ASCVD is a substantial public health burden affecting 30 million Americans,” Norman Lepor, MD, clinical professor of medicine at UCLA Geffen School of Medicine, attending cardiologist at Cedars-Sinai Heart Institute, co-director of Cardiovascular Imaging-Westside Medical Center, director of clinical research at Westside Medical Associates of Los Angeles and a clinical investigator in the phase 3 clinical program for inclisiran, said in the release. “As a first-of-its-kind siRNA therapy, Leqvio works differently than other cholesterol treatments, with twice-yearly dosing that makes it a compelling option for the millions of people with ASCVD already on cholesterol-lowering medications struggling to reach their LDL-C target.”
Perspective
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Michael H. Davidson, MD, FACC, FACP, FNLA
As a preventive cardiologist, I am very excited about the approval of inclisiran. The ability to dose the patients in the clinic every 6 months is a transformative therapy that will help clinicians to mandate compliance. Compliance to the appropriate therapies is a major hurdle for LDL guideline adherence.
My concern is that the annual price tag of $6,500 will require prior authorization, and most primary care physicians or general cardiologists may not want to allocate the resources necessary to make this novel model for lipid management work in their offices.
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