United States-based Akero Therapeutics Inc. (Nasdaq: AKRO), has received Priority Medicines (PRIME) designation from the European Medicines Agency (EMA) for efruxifermin (EFX), an investigational FGF21 analogue, intended for the treatment of non-alcoholic steatohepatitis (NASH), a non-alcoholic fatty liver disease, it was reported on Friday.
The product was granted the designation based on the positive efficacy data recently reported from the company's Phase 2a BALANCED study.
The firm is planning to start a Phase 2b/3 adaptive trial of EFX in biopsy-confirmed NASH patients in the first half of 2021, based on guidance received from the United States Food and Drug Administration (FDA).
Precigen announces FDA platform technology designation for AdenoVerse
Enhertu recommended for EU approval in early HER2-positive breast cancer
PureTech receives FDA Fast Track designation for LYT-200 in HR-MDS
MaaT Pharma outlines potential Phase 3 development plan for MaaT013 after CHMP negative opinion
Bayer's Kerendia wins FDA approval for chronic kidney disease associated with type 1 diabetes
Myosin Therapeutics chosen for 2026-2027 NCI Investor Initiatives Showcase
Medtronic receives FDA clearance for LigaSure RAS Maryland instrument on Hugo system
VaxThera partners with Codagenix for next generation yellow fever vaccine advancement
FDA approves Scholar Rock's ISEMBYLD to treat spinal muscular atrophy
FDA grants priority review to Takeda's zasocitinib application for plaque psoriasis
Armata Pharmaceuticals announces receipt of FDA Breakthrough Therapy Designation for AP-SA02
GSK reports positive Jideytro data supporting potential first-line lung cancer use