Elafibranor Receives Accelerated FDA Approval for PBC

The US Food and Drug Administration (FDA) on June 10 granted accelerated approval for elafibranor (Iqirvo®) for treatment of primary biliary cholangitis in combination with ursodeoxycholic acid (UDCA) or as monotherapy among patients who cannot tolerate UDCA.

Elafibranor is an oral, once-daily peroxisome proliferator-activated receptor (PPAR) agonist. The accelerated approval is based on positive data from the phase III ELATIVE trial, which demonstrated that 13 times more patients achieved the composite primary endpoint of biochemical response when treated with elafibranor plus UDCA (n=108, 51%) versus placebo plus UDCA (n=53, 4%).

PBC is an autoimmune, cholestatic liver disease causes irreversible fibrosis of the liver and destruction of the bile ducts. It affects approximately 100,000 people in the U.S., primarily women.

Reference:

Ipsen’s Iqirvo® receives U.S. FDA accelerated approval as a first-in-class PPAR treatment for primary biliary cholangitis. News release. Ipsen; June 10, 2024. Accessed June 13, 2024.