A new FDA-approved therapy, Iqirvo, has been developed by Ipsen to treat primary biliary cholangitis (PBC), a rare liver disease that can lead to organ failure. PBC is an autoimmune condition that causes bile and toxins to build up in the liver, leading to inflammation and damage. Iqirvo, which activates peroxisome proliferator-activated receptors (PPAR), is the third approved therapy for PBC. The drug was initially developed by Genfit for another liver disease but was redirected to focus on PBC. Ipsen acquired the rights to Iqirvo and plans to compete with other drugs like Ocaliva and seladelpar. The FDA’s accelerated approval of Iqirvo is based on positive results from a Phase 3 clinical trial, showing a reduction in alkaline phosphatase levels in PBC patients. Further clinical data may be required to maintain the drug’s approval status.
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Ipsen, Genfit Drug That Missed in MASH Wins FDA Approval in a Much Rarer Liver Disease
