Inventiva receives FDA Breakthrough Therapy designation for lead drug candidate lanifibranor in NASH
Daix (France), October 12, 2020 – Inventiva (Euronext Paris and Nasdaq: IVA), a clinical-stage biopharmaceutical company focused on the development of oral small molecule therapies for the treatment of non-alcoholic steatohepatitis (NASH), mucopolysaccharidoses (MPS) and other diseases with significant unmet medical need, today announced that the U.S. Food and Drug Administration (FDA) has granted Breakthrough Therapy designation to lanifibranor, the Company’s lead drug candidate, for the treatment of NASH. Lanifibranor is believed to be the first drug candidate to be granted this status for the treatment of NASH since January 2015.
The Breakthrough Therapy designation by the FDA is intended to expedite the development and review of drug candidates for serious or life-threatening conditions. To qualify for this designation, drug candidates must show preliminary clinical evidence that they may demonstrate a substantial improvement on at least one clinically significant endpoint over available therapies or over placebo if there are no approved therapies.