Complete Response Letters
LIB Therapeutics, Inc.: Lerochol
What FDA's Complete Response Letters to the company say, in the letters' own words.
Complete Response Letter, Dec 12, 2025
BLA 761427 provides for the use of Lerochol (lerodalcibep-liga) for the following indications which, for administrative purposes, we have designated as follows:
CRL_BLA761427_20251212:p1:s13The subject of this action letter is BLA 761427/Original 2. A separate action letter will be issued for BLA 761427/Original 1.
CRL_BLA761427_20251212:p1:s16All future submissions to BLA 761427/Original 1 and BLA 761427/Original 2 should specify the BLA number and the Original number to which each submission pertains.
CRL_BLA761427_20251212:p1:s17We have completed the review of BLA 761427/Original 2 as amended and have determined that we cannot approve this application in its present form.
CRL_BLA761427_20251212:p1:s18The mean LDL-C reduction by intent-to-treat (ITT) analysis at Week 24 was -4.9% when subjects were receiving Lerochol (also referred to as LIBO03) and -10.3% when the same subjects were receiving evolocumab.
CRL_BLA761427_20251212:p1:s25Given concerns for the cross-over design of the trial, an additional analysis of the primary efficacy endpoint for Period A only was performed.
CRL_BLA761427_20251212:p1:s30Lerochol is effective for the proposed indication.
CRL_BLA761427_20251212:p1:s35More Complete Response Letters
Updated Sep 30, 2026 · built from 283 companies in the EphemerisX knowledge graph. This page is regenerated as companies are added.