IVA - Inventiva nabs Breakthrough Device tag for its lead candidate for NASH

The FDA designates Inventiva's (IVA) lanifibranor, a Breakthrough Therapy for the treatment of non-alcoholic steatohepatitis ((NASH))The Breakthrough Therapy designation expedites the development and review of drug candidates, as well as provides for more intensive guidance from the FDA on development, involves more senior agency personnel and a rolling review of the marketing application. The company plans to hold the end of NATIVE Phase IIb trial meeting with the FDA and receive regulatory feedback from the EMA for lanifibranor, by the end of this year, and initiate pivotal Phase 3 with lanifibranor in H1 of 2021.Lanifibranor induces anti-fibrotic, anti-inflammatory and beneficial vascular and metabolic changes in the body by activating all three peroxisome proliferator?activated receptor ((PPAR)) isoforms, which are well?characterized nuclear receptor proteins that regulate gene expression.

For further details see:

Inventiva nabs Breakthrough Device tag for its lead candidate for NASH