Leqvio FDA Approval slide image

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 Medicine
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