FDA OKs Iqirvo, First-in-Class PPAR Treatment for PBC

The FDA has granted accelerated approval for Iqirvo for the treatment of primary biliary cholangitis in adults who do not respond adequately to UDCA or cannot tolerate it. PBC is a rare liver disease that can lead to cirrhosis and liver transplant if untreated. Iqirvo, the first new drug for PBC in nearly a decade, showed favorable results in a phase 3 trial, with a biochemical response seen in a higher percentage of patients compared to placebo. Common side effects include weight gain, abdominal pain, diarrhea, nausea, and vomiting. Iqirvo is not recommended for those with decompensated cirrhosis. Its approval will help address an unmet need for PBC patients.

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