The European Medicines Agency recommends marketing authorization for Seladelpar Gilead for treating primary biliary cholangitis (PBC), a chronic liver disease primarily affecting women. Seladelpar helps normalize ALP and bilirubin levels in adults with PBC and has shown promising results in a phase 3 trial, reducing pruritus and delaying liver fibrosis. Common side effects include abdominal pain, headache, nausea, and abdominal distension. Seladelpar is indicated for use in combination with UDCA or as monotherapy for PBC patients who do not respond to UDCA. Further clinical data will be required after European Commission authorization. Seladelpar was supported through the EMA’s PRIME scheme.
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EMA Recommends Seladelpar for Primary Biliary Cholangitis
