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Non-alcoholic fatty liver disease is a type of disease characterized by liver fat that still occurs without excessive drinking, which may progress to cirrhosis and may be an important cause of recessive cirrhosis.
pharmaceutical company Akero Therapeutics announced today that the research FGF21 similar efruxifermin (EFX) treatment of non-alcoholic fatty hepatitis (NASH) has been awarded the European Medicines Agency(EMA) "Priority Drug Title" (PRIME).
positive efficacy data from the company's recent IIa Phase BALANCED study supported the EMA's decision.
based on available publicly available data, Efruxifermin (EFX) is believed to be the first NASH treatment to receive PRIME.
Andrew Cheng, President and CEO of Akero Therapeutics, said, "This title highlights not only the medical need to treat this life-threatening disease, but also the potential of EFX to address NASH and its associated mergers."
decision, the EMA's Human Medicines Council (CHMP) noted that preliminary 16-week data from Akero's Phase IIa clinical trial showed that EFX could improve NASH-related morbidity and mortality.
CHMP also said that all data, including histological and biomarker data, showed that EFX had the potential to treat NASH.
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