August 01, 2025
1 min read
Key takeaways:
- Inclisiran is now FDA approved as monotherapy for LDL reduction.
- The drug is no longer required to be used on top of or together with statin therapy.
Novartis announced the FDA approved updated labeling for inclisiran, a small-interfering RNA therapy, for use as monotherapy on top of diet and exercise to reduce LDL in adults with hypercholesterolemia.
As Healio previously reported, the FDA approved inclisiran (Leqvio) for LDL lowering, administered once every 6 months after an initial dose and one at 3 months.
Inclisiran is administered twice per year via subcutaneous injection, and the updated label removes the requirement for inclisiran to be used on top of or in combination with statin therapy, according to a company press release.
In addition, the term “primary hyperlipidemia” was changed to “hypercholesterolemia” throughout on the label, to put a larger focus on LDL reduction, according to the release.
“This first-line label update reinforces Leqvio’s proven ability to effectively lower LDL-C, a critical risk factor for heart disease,” Victor Bultó, president of Novartis U.S., said in the release. “With this new indication enabling Leqvio’s use as monotherapy along with diet and exercise, we now have the potential to help even more patients achieve their LDL-C lowering goals earlier in their treatment journey.”
