Posted by Michael Wonder on 14 Feb 2025
LIB Therapeutics announces FDA acceptance of biologics license application for lerodalcibep to lower LDL-cholesterol across broad patient population
10 February 2025 - FDA has set a PDUFA target action date of 12 December 2025.
LIB Therapeutics today announced the US FDA has accepted for review the biologics license application of lerodalcibep to reduce low-density lipoprotein cholesterol for the treatment of patients with atherosclerotic cardiovascular disease (ASCVD), or very high or high risk of ASCVD, and primary hyperlipidaemia, including heterozygous, and those 10 years or older with homozygous familial hypercholesterolaemia.
