FDA expands inclisiran indication to primary prevention patients
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Key takeaways:
- The FDA approved an expanded indication for inclisiran to include patients with high LDL but without a history of CVD.
- The label update allows for earlier use of the cholesterol-lowering therapy.
The FDA approved a label update for inclisiran to include people with elevated LDL and other risk factors such as hypertension and diabetes who have not experienced a CV event, Novartis announced.
The company stated in a press release that the expanded indication for inclisiran (Leqvio), a small-interfering RNA therapy for LDL lowering, will enable earlier use for patients with elevated LDL who have an increased risk for CVD, as an adjunct to diet and statin therapy. The FDA approved inclisiran in 2021 for adults with clinical atherosclerotic CVD or heterozygous familial hypercholesterolemia who require additional LDL lowering.
After an initial dose and one at 3 months, inclisiran is administered twice per year as a subcutaneous injection.
“High LDL is one of the most readily modifiable risk factors for heart disease and this label update for Leqvio will help us reach a greater number of patients who struggle with lowering their LDL,” Victor Bulto, president of Novartis Innovative Medicines U.S., said in the release.
As Healio previously reported, initial data from ORION-3 demonstrated inclisiran injections administered twice per year safely reduced LDL by at least 50% out to 3 years in adults with atherosclerotic CVD or a risk equivalent. In the phase 2, open-label extension study, researchers demonstrated that twice-yearly inclisiran injections were associated with a 44% reduction in LDL that was sustained over 4 years with no new safety signals observed.
Other updates to the inclisiran label include the removal of the “limitations of use” statement and the safety section was streamlined to remove four adverse events, since the frequency of the events were the same as the placebo arm, according to Novartis.
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