HST-101

Novartis's LEQVIO (inclisiran), the first FDA-approved siRNA therapy for LDL-C reduction, is projected to reach USD 2.2 billion in US market size by 2034, offering a novel mechanism with biannual dosing that enhances patient adherence.

The FDA has accepted the regulatory application for lerodalcibep, a novel therapeutic candidate aimed at reducing LDL cholesterol levels in patients with hypercholesterolemia.

2024 marked significant progress in lipid management, with notable advancements in the treatment of familial chylomicronemia syndrome (FCS) and lipoprotein(a) (Lp(a)) management. However, the year also saw challenges to the 'HDL hypothesis', highlighting the complexity of lipid-related cardiovascular disease prevention. Key developments included FDA approvals of novel therapies and promising results from clinical trials targeting triglycerides and Lp(a).

The FDA has accepted LIB Therapeutics' BLA for lerodalcibep, a PCSK9 inhibitor, with a PDUFA date set for December 12, 2025.

Lerodalcibep demonstrated similar LDL-C reduction compared to evolocumab in HoFH patients in a Phase 3 trial.