Posted by Michael Wonder on 03 Jul 2026
Selective PPARα modulator “K-808” (pemafibrate) granted breakthrough therapy designation by the US FDA as a treatment for primary biliary cholangitis
30 June 2026 - Kowa today announced that on 11 June 2026, it received breakthrough therapy designation from the US FDA for “K-808” (pemafibrate) for the treatment of patients with primary biliary cholangitis.
K-808 was designated as a breakthrough therapy based on preliminary data and evidence from the on-going Phase 2 clinical trial (K-808-2.01).
