U.S. FDA Updates LDL-C Lowering Indication for Esperion’s NEXLETOL

  Updated Label Adds Primary Hyperlipidemia, Removes Maximally Tolerated Statin Requirement, Removes Limitation of Use –

– Cardiovascular (CV) Risk Reduction Labels Remain on Track: in U.S. with PDUFA Date of March 31; in Europe with Anticipated Approval in 1H 2024 –

https://www.globenewswire.com/news-release/2023/12/13/2795859/0/en/U-S-FDA-Updates-LDL-C-Lowering-Indication-for-Esperion-s-NEXLETOL-bempedoic-acid-Tablet-and-NEXLIZET-bempedoic-acid-and-ezetimibe-Tablet.html