FDAnews Drug Daily Bulletin
Pharmaceuticals / Regulatory Affairs

FDA Grants Genfit Breakthrough Designation for PBC Disease 

April 29, 2019
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Genfit’s elafibranor earned the FDA’s breakthrough therapy designation for treating primary biliary cholangitis (PBC), a rare autoimmune disease that affects the liver.

The oral, once-daily drug was developed to treat nonalcoholic steatohepatitis (NASH). But the drug developer believes that clinical results from a Phase 2 trial suggest it may be effective for treating PBC.

The chronic disease progressively destroys bile ducts in the liver, which can lead to cirrhosis and bile backups.

The breakthrough designation is “further confirms our strong belief that elafibranor could potentially address this significant unmet medical need,” said Genfit’s chief medical officer Pascal Birman.

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