Shots:

• The CHMP’s positive opinion is based on ORION program including P-III studies assessing Leqvio in 3-600+ patients on a maximally tolerated statin dose. Inclisiran demonstrated effective and sustained LDL-C reduction of up to 52% with 2doses/yr- after an initial dose and one @3mos.- in adults with ASCVD- ASCVD risk equivalent or HeFH6
• 80% of high-risk patients do not reach guideline-recommended LDC-L- targets despite the widespread use of statins. Reduction in LDL-C was achieved through 17mos. with a safety and tolerability profile like PBO
• Additional post hoc analysis demonstrated 88% of them reached guideline-recommended targets at any timepoint during the study. Additionally- the therapy is also under review by the US FDA and other health authorities for primary hyperlipidemia in adults who have elevated LDL-C while being on a maximally tolerated dose of statin therapy

 ­ Ref: Novartis | Image: Novartis