Brief: Ipsen, Genfit Announce Positive Results From Phase III ELATIVE Trial Of Elafibranor

Genfit SA

30/06/2023 06:12

June 30 (Reuters) - Genfit SA  GNFT.PA , IPSEN  IPN.PA :
    * IPSEN AND GENFIT ANNOUNCE POSITIVE RESULTS FROM PHASE III
ELATIVE® TRIAL OF ELAFIBRANOR IN PATIENTS WITH PRIMARY BILIARY
CHOLANGITIS, A RARE CHOLESTATIC LIVER DISEASE
    * TRIAL MET PRIMARY ENDPOINT WITH A STATISTICALLY
SIGNIFICANT
HIGHER PERCENTAGE OF PATIENTS ACHIEVING A CLINICALLY MEANINGFUL
CHOLESTASIS RESPONSE COMPARED TO PLACEBO
    * ELAFIBRANOR WAS WELL TOLERATED WITH A SAFETY PROFILE
CONSISTENT
WITH PREVIOUS STUDIES
    * RESULTS POSITION ELAFIBRANOR AS A POTENTIALLY IMPORTANT
NEW
TREATMENT OPTION, WHERE THERE IS STILL HIGH UNMET NEED
    * IPSEN INTENDS TO SUBMIT REGULATORY APPLICATIONS FOR
ELAFIBRANOR
FOLLOWING DISCUSSIONS WITH U.S. FOOD AND DRUG ADMINISTRATION
(FDA) AND EUROPEAN MEDICINES AGENCY (EMA)

Source text for Eikon:  ID:nGNE8DTJ5 
Further company coverage:  GNFT.PA 

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