Posted by Michael Wonder on 27 Sep 2019
Inventiva receives FDA fast track designation for lead asset lanifibranor in NASH
26 September 2019 - Designation is intended to facilitate the development and expedite the regulatory review of lanifibranor for the treatment of NASH.
Inventiva today announced that the U.S. FDA has granted fast track designation for the Company’s lead product candidate, lanifibranor, for the treatment of non-alcoholic steatohepatitis (NASH).
The FDA’s decision follows the completion of patient recruitment for Inventiva’s NATIVE (NAsh Trial to Validate IVA337 Efficacy) Phase IIb clinical study evaluating the drug candidate for the treatment of NASH. The study is progressing as planned and the publication of the results are expected in the first half of 2020. If positive, they will support the entry of lanifibranor into the pivotal Phase III trial, the last phase of its development prior to market launch.
