IMMEDIATE: Thousands of people living with a debilitating liver disease set to benefit after NICE approves new treatment option

Thousands of people living with a chronic liver condition are set to benefit from a new daily pill that tackles both the disease itself and one of its most distressing symptoms - persistent, severe itching. 

Seladelpar, also known as Livdelzi and made by Gilead, is recommended to treat primary biliary cholangitis (PBC), including severe itching - known as pruritus - in adults.  

It is estimated that around 3,700 people in England will be eligible to receive the new treatment. 

PBC is a chronic autoimmune disease where the body’s immune system mistakenly attacks and slowly destroys the small bile ducts within the liver. Over time, this can cause serious liver damage, including scarring and liver failure, and in some cases can require a liver transplant.   

Many people with PBC experience symptoms that can have a severe impact on their daily lives. This includes persistent itching and extreme fatigue that can disrupt sleep, affect people’s ability to work, and take a significant toll on mental health and family life. 

Seladelpar, given as a daily pill, reduces elevated liver enzyme levels, which are an indicator of the disease progressing. In a clinical trial, one in four people on seladelpar saw their liver enzyme levels return to normal, compared with none in the placebo group. This suggests the treatment could help slow the progression of the disease. 

Seladelpar is also specifically licensed to treat pruritus caused by PBC. Evidence suggests it may reduce moderate to severe itching more effectively than obeticholic acid, one of the currently available second-line treatments. 

The treatment is recommended for people whose condition has not responded well enough to the standard first treatment, ursodeoxycholic acid, or who cannot tolerate it.  

The condition disproportionately affects women, who make up around 90% of those diagnosed with PBC, and is most commonly diagnosed in people over 40. It affects around 20,000 people in the UK.  

The company has a confidential commercial arrangement through a simple discount patient access scheme that makes seladelpar available to the NHS with a discount.  

NHS England will provide the treatment within three months of NICE publishing final guidance.  

Read the full final draft guidance on seladelpar for previously treated primary biliary cholangitis. 

ENDS