Inventiva (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 decided that the Fast Track designation previously granted to lanifibranor in NASH encompasses the treatment of NASH patients with compensated cirrhosis.

This decision follows a Fast Track designation request for lanifibranor in NASH with compensated cirrhosis filed by Inventiva with the FDA in August 2021. Previously, the FDA had granted both Fast Track and Breakthrough Therapy designations to lanifibranor for the treatment of NASH in September 2019 and October 2020, respectively.

The FDA’s dedicated Fast Track program is designed to facilitate the development and expedite the review and potential approval of drug candidates demonstrating the capacity to treat serious conditions and fill significant unmet medical needs.

Pierre Broqua, Ph.D., Chief Scientific Officer and cofounder of Inventiva, commented: “We are delighted to have a Fast Track designation for lanifibranor in NASH that extends to the treatment of NASH with compensated cirrhosis, a very severe stage of the disease where patients are in urgent need of treatment. The FDA decision does not only recognize this urgency but also the potential of lanifibranor to address this crucial unmet medical need. This news reinforces our confidence in the unique mechanism of action of our lead drug candidate and confirms our determination to accelerate the development of lanifibranor in its pivotal phase.”

NASH with compensated cirrhosis represents a serious stage of the disease and is becoming the leading cause for liver transplantation, which today represents the only available treatment option for patients who have progressed to end-stage NASH. There is thus an urgent need to develop pharmacological therapies to slow down or halt the progression towards NASH with compensated cirrhosis for NASH patients who are at an increased risk of liver-related morbidity and mortality.

Given the broad range of activity of lanifibranor as a pan-PPAR agonist on multiple features of NASH, including beneficial effects on metabolism, inflammation, ballooning, fibrosis and vascular manifestations, Inventiva believes that there is a strong rationale to evaluate the efficacy of lanifibranor in NASH patients with compensated cirrhosis.