Genfit (GNFT) announced that it had received Breakthrough Therapy Designation for its drug Elafibranor to treat patients with primary biliary cholangitis ((PBC)). The designation was given based on newly updated data presented at the EASL International Liver Congress 2019. This will help Genfit speed up the review process for potential FDA approval. A competing drug from Intercept Pharmaceuticals (ICPT), known as Ocaliva, has already been approved by the FDA to treat patients with PBC.
Breakthrough Designation Based On Impressive Data
Elafibranor was given Breakthrough Therapy Designation based on positive phase 2