Livdelzi (seladelpar)
Livdelzi is approved to treat primary biliary cholangitis (PBC) in adults in combination with ursodeoxycholic acid (UDCA) when UDCA alone isn't effective, or on its own if UDCA can’t be tolerated. Livdelzi contains the active ingredient seladelpar.
Livdelzi is approved to treat primary biliary cholangitis (PBC) in adults in combination with another medicine, ursodeoxycholic acid (UDCA), when UDCA alone doesn’t work well enough, or on its own if UDCA can’t be tolerated.
PBC is a rare long-term condition where the body’s immune system slowly damages bile ducts (small tubes that carry bile from the liver to the intestines). Bile helps the body digest fats and remove waste products.
When the bile ducts become inflamed or destroyed it can lead to:
- a build up of bile acids in the liver (called cholestasis), which can cause ongoing liver inflammation and scarring of the liver over time
- a higher risk of cirrhosis (permanent liver scarring) and liver cancer if the condition is not treated
- itching (pruritis), fatigue, and other symptoms.
Treatment for PBC generally focuses on reducing cholestasis, protecting the liver, and easing symptoms such as itching.
Livdelzi works by activating a natural system in the body called the PPAR‑delta (PPAR‑δ) pathway. This pathway is thought to help:
- the liver make fewer bile acids and the body clear them, reducing pressure and inflammation in the bile ducts
- protect the liver
- reduce itching by lowering inflammation signals in the body, including one called interleukin-31 (IL-31).
The effectiveness and safety of Livdelzi were assessed in one main clinical study and several supporting studies.
The main study included 193 adult patients with PBC who did not respond adequately to UDCA or were intolerant to UCDA. This study assessed whether Livdelzi improved liver function, based on blood tests, with a focus on alkaline phosphatase (ALP). ALP is a liver enzyme, and its levels in the blood often rise when bile ducts are blocked or inflamed. The study also measured blood levels of bilirubin, which can increase when the liver or bile ducts aren’t working properly.
Other aims of the main study were to assess changes in itching, based on participant surveys, and to assess adverse events.
Key findings from clinical studies of Livdelzi
- More patients taking Livdelzi had improved blood levels of ALP and bilirubin compared with patients taking a placebo (a treatment with no active medicine). In addition, more patients taking Livdelzi reached normal ALP levels.
- Livdelzi treatment also reduced itching in patients with moderate to severe symptoms, compared with patients taking a placebo.
- Overall, Livdelzi was found to be well tolerated. Most adverse events were considered mild to moderate. The most common reported adverse events based on the clinical trial experience were abdominal pain and nausea.
- More data is needed on longer-term improvements in patients’ liver function and longer-term safety. The sponsor company is carrying out more research to better understand the longer-term safety and effectiveness of Livdelzi.
The TGA decided that the application provided sufficient evidence to support the safety and effectiveness of Livdelzi and that the medicine can be registered for use in Australia.
More detailed information on why the TGA approved Livdelzi will be published in the upcoming Australian Public Assessment Report (AusPAR).
For comprehensive information on potential side effects and risks, refer to the Consumer Medicine Information (CMI) leaflet or Product Information (PI) document (available through the Livdelzi ARTG record).
The information in this decision summary will not be updated to include any subsequent changes, so may not represent the most current information for a medicine. For current information, refer to the medicine’s CMI or PI.
The CMI leaflet offers guidance for consumers to support safe and effective use of the medicine. The CMI includes information on dose, how to use the medicine properly, potential side effects, safety precautions, storage instructions and more.
The Australian CMI for Livdelzi can be accessed through the Livdelzi ARTG record.
The PI document provides essential prescribing information for health professionals, including details on dosage recommendations, pregnancy category, contraindications, precautions and potential side effects.
The Australian PI for Livdelzi can be accessed through the Livdelzi ARTG record.
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