Shots:
- The US FDA has approved Lerochol as an LDL-C lowering therapy for adults with hypercholesterolemia, including HeFH; US launch as a PFS is expected in spring 2026, with an autoinjector later in 2026, while EMA approval is anticipated in Jun 2026 alongside additional global regulatory filings
- Approval was supported by the global P-III (LIBerate) trial, enrolling over 2,900 CVD patients and without CVD at very and high risk of developing CVD, including HeFH; QM lerodalcibep for up to 52 wks. and over 2400 pts continued with a 72-wk extension. Lerochol achieved sustained LDL-C reductions of ~60% and was generally well tolerated
- Lerochol is a third-generation PCSK9 inhibitor with an 11-kDa polypeptide aka adnectin with high-affinity subnanomolar PCSK9 binding fused to human serum albumin to extend plasma half-life.
Ref: LIB Therapeutics| Image: LIB Therapeutics|Press Release
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