Shots:

• The approval was based on the P-III (ORION-9/10/11) clinical trials to evaluate Leqvio vs PBO in 3,457 patients with ASCVD or HeFH who require additional lowering of LDL-C while receiving an MTD of statin therapy
• In the P-III trials, the therapy showed an effective and sustained LDL-C reduction of 52% compared to PBO @17mos. The therapy was well-tolerated with a safety profile
• Under a license and collaboration agreement with Alnylam, Novartis got the rights globally to develop, manufacture & commercialize Leqvio. Additionally, Leqvio is the first siRNA therapy to reduce LDL-C with 2 doses/yr., following an initial dose and a dose at 3mos.

Ref: Novartis | Image: Novartis