Leqvio FDA Approval slide image

Leqvio FDA Approval

LeqvioⓇ delivers effective and sustained³ LDL-C reduction of up to 52%1,2 with twice-yearly HCP-administered dosing LeqvioⓇ effected significant reductions in LDL-C vs. placebo at Day 510, on top of SoC % Change in LDL-C from baseline LeqvioⓇ ORION-105 ORION-115,6 ORION-95 -51 -466 -40 Placebo 1 46 8 Difference between groups (in mean percentage change) -52% (p<0.0001) -51%6 (p < 0.0001) -48% (p<0.0001) LDL-C - Low Density Lipoprotein Cholesterol. ASCVD - Atherosclerotic Cardiovascular Disease. HCP Healthcare Professional SoC - standard of care 1. Two Phase 3 Trials of Inclisiran in Patients with Elevated LDL Cholesterol Kausik K. Ray, M.D., M.Phil., R. Scott Wright, M.D., David Kallend, M.D., Wolfgang Koenig, M.D., Lawrence A. Leiter, M.D., Frederick J. Raal, Ph.D., Jenna A. Bisch, B.A., Tara Richardson, B.A., Mark Jaros, Ph.D., Peter L.J. Wijngaard, Ph.D., and John J.P. Kastelein, M.D., Ph.D., for the ORION-10 and ORION-11 Investigators*; March 18, 2020, at NEJM.org.DOI: 10.1056/NEJMoa1912387. 2. Inclisiran for the Treatment of Heterozygous Familial HypercholesterolemiaFrederick J. Raal, M.D., Ph.D., David Kallend, M.B., B.S., Kausik K. Ray, M.D., M.Phil., Traci Turner, M.D., Wolfgang Koenig, M.D., R. Scott Wright, M.D., Peter L.J. Wijngaard, Ph.D., Danielle Curcio, M.B.A., Mark J. Jaros, Ph.D., Lawrence A. Leiter, M.D., and John J.P. Kastelein, M.D., Ph.D., for the ORION-9 Investigators*; March 18, 2020, at NEJM.org.DOI: 10.1056/NEJMoa1913805. 3. Across the 6-month dosing interval. 4. After an initial dose, again at 3 months, and again every six months thereafter. As a strong complement to a maximally tolerated statin 5. LeqvioⓇ prescribing information East Hanover, NJ. Novartis: 2021 6. ASCVD subjects only; ASCVD-Risk Equivalents excluded from analysis 12 LeqvioⓇ FDA Approval | December 23, 2021 | Novartis Investor Presentation V NOVARTIS | Reimagining Medicine
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