To learn more , visit : https :// ascvd . medhub . com . au / en-au / clinical-benefits
LEQVIO ( inclisiran ) IS NOW PBS LISTED
LDL
CONTROL .†
NOW IN YOUR
HANDS .‡
C
† 86.8 % of LEQVIO-treated patients achieved LDL-C < 1.8 mmol / L at any post-baseline visit a1
‡HCP-administered injection at day 1 , 3 months , then 6-monthly thereafter 2
LEQVIO OFFERS
Long-lasting LDL-C reduction # 1
#
LDL-C reduction of ~ 50 % with LEQVIO vs placebo maintained over the 540-day ( 18-month ) trial period ( p < 0.0001 ) a1
2x
Twice-yearly dosing^2
^
HCP-administered injection at day 1 , 3 months , then 6-monthly thereafter 2
To learn more , visit : https :// ascvd . medhub . com . au / en-au / clinical-benefits
In patients exposed to LEQVIO ( n = 1,833 ) or placebo ( n = 1,822 ) for up to 18 months , the incidence of TEAEs was similar between treatment groups except for injection site reactions ( 8.2 % LEQVIO vs 1.8 % placebo ), which were mild or moderate in severity , transient and resolved without sequelae , and bronchitis ( 4.3 % vs 2.7 %). a1 , 2
a
Pooled patient-level analysis of ORION-9 , -10 and -11 phase 3 trials of LEQVIO vs placebo in 3,660 adult patients ( 3,655 in safety population ) with HeFH , ASCVD or ASCVD risk equivalents ( T2DM , FH and 10-year risk of a CV event > 20 % as assessed by Framingham risk score ) and LDL-C above target of 1.8 mmol / L , on a background of maximally tolerated statin ( unless intolerant or contraindicated ) ± ezetimibe . Co-primary endpoints : placebo-corrected reduction from baseline in LDL-C at Day 510 ( 17 months ) of 50.7 % ( 95 % CI -52.9 , -48.4 ; p < 0.0001 ); placebo-corrected time-adjusted reduction in LDL-C from baseline between Day 90 ( 3 months ) and Day 540 ( 18 months ) of 50.5 % ( 95 % CI -52.1 , -48.9 ; p < 0.0001 ). 1
ASCVD , atherosclerotic cardiovascular disease ; CI , confidence interval ; CV , cardiovascular ; FH , familial hypercholesterolaemia ; HCP , healthcare professional ; HeFH , heterozygous familial hypercholesterolaemia ; LDL-C , low-density lipoprotein cholesterol ; T2DM , type two diabetes mellitus ; TEAE , treatment-emergent adverse event .
References : 1 . Wright RS et al . J Am Coll Cardiol 2021 ; 77 : 1182 – 1193 . 2 . LEQVIO ( inclisiran ) Australian approved Product Information .
PBS Information : Authority Required ( telephone / online ) for patients with hypercholesterolaemia . Refer to PBS Schedule for full Authority information .
This medicinal product is subject to additional monitoring in Australia . This will allow quick identification of new safety information . Healthcare professionals are asked to report any suspected adverse events at www . tga . gov . au / reporting-problems .
For healthcare professionals only . Please review Product Information before prescribing . Scan QR code for full LEQVIO Product Information .
Alternatively , please contact med info on 1800 671 203 or visit www . novartis . com . au / products / healthcare-professionals to access the full Product Information .
PLEQ1021
LEQVIO ® and the LEQVIO ® logo are registered trademarks of Novartis AG . Licensed from Alnylam Pharmaceuticals , Inc . © 2024 Novartis Pharmaceuticals Australia Pty Limited . ABN 18 004 244 160 . 54 Waterloo Road , Macquarie Park NSW 2113 . Ph ( 02 ) 9805 3555 . For medical enquiries please contact 1800 671 203 or medinfo . phauno @ novartis . com . AU-25515 . NOIN31795M . February 2024 .