Leqvio FDA Approval
Leqvio® has a well tolerated safety profile
No significant safety or tolerability concerns identified with the long-term* administration of LeqvioⓇ1,2
ORION-9 (n=481)1
LeqvioⓇ
ORION-10 (n=1,559)²
ORION-11 (n=1,615)²
Placebo
LeqvioⓇ
Placebo
LeqvioⓇ
Placebo
n=241
n=240
n=781
n=778
n=811
n=804
Safety population
n
%
n
%
n
%
n
%
n
%
n
%
Patients with at least
18
7.5%
33
13.8%
175
22.4%
205
26.3%
181
22.3%
181
22.5%
one serious TEAE
Pre-specified exploratory CV
10
4.1%
10
4.2%
58
7.4%
79
10.2%
63
7.8%
83
10.3%
endpoint (MedDRA basket)
■ Most common adverse events with similar frequency in LeqvioⓇ and placebo groups
■ Adverse events associated with LeqvioⓇ were all mild or moderate in severity, transient and resolved without sequelae
■ Common adverse reactions (≥ 3%) include injection site reaction, arthralgia, urinary tract infection, diarrhea, bronchitis,
pain in extremity, and dyspnea
CV Cardiovascular TEAE - Treatment Emergent Adverse Event
*Over 18 months. 1. 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. 2. Two Phase 3 Trials of Inclisiran in Patients with Elevated LDL CholesterolKausik 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.
13 Leqvio® FDA Approval | December 23, 2021 | Novartis Investor Presentation
V NOVARTIS | Reimagining MedicineView entire presentation