Kowa’s K-808 Receives FDA Breakthrough Therapy Designation for Primary Biliary Cholangitis
Kowa Company has announced that the US Food and Drug Administration (FDA) has granted Breakthrough Therapy designation to its investigational therapy, K-808 (pemafibrate), for the treatment of primary biliary cholangitis (PBC).
The designation was awarded on 11 June and is intended to accelerate the development and regulatory review of medicines that show the potential to offer significant improvements over existing treatments for serious diseases.
The FDA's decision is based on preliminary findings from the ongoing Phase II K-808-2.01 clinical trial, which indicate that K-808 may provide better outcomes than current treatment options.
The study demonstrated a meaningful reduction in alkaline phosphatase (ALP) levels, an important marker used to assess disease activity in patients with PBC.
Early trial results were presented at the European Association for the Study of the Liver (EASL) Congress in May 2026.
K-808 is being developed for adults with PBC who do not respond adequately to ursodeoxycholic acid (UDCA), the current standard treatment, or who are unable to tolerate it.
The therapy is being evaluated both in combination with UDCA and as a standalone treatment.
Kowa is continuing the global development of K-808 with the goal of securing regulatory approvals in key markets, including the United States and Japan, to provide an additional treatment option for patients living with primary biliary cholangitis.
