IQIRVO indicated for the treatment of primary biliary cholangitis (PBC)

IQIRVO is a peroxisome  proliferator-activated  receptor (PPAR)  agonist  indicated for the treatment of primary biliary cholangitis (PBC) in combination with ursodeoxycholic acid  (UDCA)  in  adults  who  have  an inadequate response to UDCA, or as  monotherapy in patients unable to  tolerate UDCA. This indication is approved under accelerated approval based on reduction of alkaline phosphatase (ALP).  Improvement in survival or prevention of liver decompensation events have not been demonstrated. Continued approval for this indication may be contingent upon verification and description of clinical benefit in confirmatory trial(s). Limitations of Use: Use of IQIRVO is not recommended in patients who have or develop decompensated cirrhosis (e.g., ascites, variceal bleeding, hepatic encephalopathy)