Leqvio FDA Approval
Leqvio® is now approved in the US with a label that contains no
contraindications, warnings/precautions, or drug interactions
Indication statement¹
LeqvioⓇ is indicated as an adjunct to diet and maximally tolerated statin therapy
for the treatment of adults with heterozygous familial hypercholesterolemia
(HeFH) or clinical atherosclerotic cardiovascular disease (ASCVD), who require
additional lowering of low-density lipoprotein cholesterol (LDL-C).
Limitations of use: The effect of LeqvioⓇ on cardiovascular morbidity and
mortality has not been determined.
16m addressable ASCVD
patients not at LDL-C goal
Dosage and administration¹
The recommended dosage of LeqvioⓇ, in combination with maximally tolerated
statin therapy, is 284 mg administered as a single subcutaneous injection
initially, again at 3 months, and then every 6 months; LeqvioⓇ should be
administered by a healthcare professional.
May seamlessly integrate into
a patient's health care routine
Medical benefit coverage
expected
HeFH-Heterozygous Familial Hypercholesterolemia ASCVD Atherosclerotic Cardiovascular Disease. LDL-C - Low Density Lipoprotein Choletsterol 1. LeqvioⓇ prescribing information East Hanover, NJ. Novartis: 2021
15 Leqvio® FDA Approval | December 23, 2021 | Novartis Investor Presentation
V NOVARTIS | Reimagining MedicineView entire presentation