/EMA/PE/0000242923
NEWS

EMA/PE/0000242923

EMA
2026/07/14

EMA/PE/0000242923

Key facts

Active substance

Lerodalcibep

Therapeutic area

Metabolism and nutrition disorders

Decision number

EMA/PE/0000242923

PIP number

EMA/PE/0000242923

Pharmaceutical form(s)

Solution for injection

Condition(s) / indication(s)

Treatment of hypercholesterolaemia

Route(s) of administration

Subcutaneous use

Contact for public enquiries

LIB Therapeutics Inc. Email: [email protected] Tel: +1 7347301170

Decision type

PM: decision on the application for modification of an agreed PIP

Decision date

05/05/2025

Compliance check done

No

Decision

EMA/PE/0000242923: EMA decision of 5 May 2025 on the acceptance of a modification of an agreed paediatric investigation plan for lerodalcibep

Adopted

Reference Number:

EMADOC-1700519818-2101381

English (EN) (212.36 KB - PDF)

First published:

14/07/2026

View

Summary

EMA/PE/0000242923