EMA/PE/0000232769

## Key facts Active substance pegozafermin Therapeutic area Hepatobiliary disorders Decision number EMA/PE/0000232769 PIP number EMA/PE/0000232769 Pharmaceutical form(s) Solution for injection Condition(s) / indication(s) Treatment of metabolic dysfunction-associated steatohepatitis Route(s) of administration Subcutaneous use Contact for public enquiries 89Bio Lithuania UAB Tel. +1 4154329270 E-mail: enlighten@89bio.com Decision type P: decision agreeing on a investigation plan, with or without partial waiver(s) and or deferral(s) Decision date 20/03/2025 Compliance check done No ## Decision EMA/PE/0000232769 : EMA decision of 20 March 2025 on the agreement of a paediatric investigation plan and on the granting of a deferral and on the granting of a waiver for pegozafermin Adopted Reference Number: EMADOC-1700519818-1976525 English (EN) (235.89 KB - PDF) First published: 04/06/2026 View