Future Focus

Accelerated approval has been granted for Gilead Science’s Livdelzi (seladelpar) to treat primary biliary cholangitis (PBC) by the US Food and Drug Administration (FDA).

PBC is a rare and chronic inflammatory liver disease, primarily affecting women. The disease currently has no cure and can cause liver damage with the possibility of liver failure if left untreated.

Clinical and preclinical trial data for seladelpar have shown evidence that the drug has the ability to regulate genes involved in bile acid synthesis, inflammation, lipid metabolism and transport, and fibrosis, leading to a reduction in alkaline phosphate. Data such as improvement in survival or prevention of liver decompensation events have not yet been demonstrated.

CEO and chairman of Gilead Sciences, Daniel O’Day, commented: “People living with PBC have been waiting for treatment advancements for many years. We look forward to leveraging Gilead’s long-standing expertise in liver disease to bring this promising new treatment to all those who could benefit.”

In a placebo-controlled study titled RESPONSE, seladelpar, given alone or in combination with UDCA as an oral, once-daily medicine was shown to reduce pruritus (chronic itch), which is a common symptom that can significantly impair quality of life in people with PBC. The combination also reduced key biomarkers of PBC disease.

Carol Roberts, president, The PBCers organisation stated: “The availability of a new treatment option that can help reduce this intense itching while also improving biomarkers of active liver disease is a milestone for our community.”

Seladelpar has also been accepted for review by the UK Medicines and Health products Regulatory Agency (MHRA) and the European Medicines Agency (EMA).