Primary biliary cholangitis drug Livdelzi’s launch imminent

Gilead Korea’s application under MFDS review

Phase III RESPONSE confirms ALP Improvement

A new treatment for primary biliary cholangitis (PBC), Livdelzi, may soon enter the Korean market.

 

Gilead Sciences Korea recently submitted a marketing authorization application for Livdelzi (seladelpar), an oral therapy for adults with PBC who show inadequate response or intolerance to ursodeoxycholic acid (UDCA).

 

The application is currently under review by the Ministry of Food and Drug Safety.

 

Livdelzi was designated as a Global Innovative product on Fast Track (GIFT) in June and as an orphan drug in August in Korea.

 

PBC is a rare, intractable autoimmune disease characterized by chronic inflammation and destruction of intrahepatic bile ducts.

 

This leads to cholestasis and liver damage, which ultimately progresses to cirrhosis or liver failure.

 

While ursodeoxycholic acid (UDCA) is currently used as the first-line treatment, there has been a persistent need for new therapeutic strategies for patients who have an insufficient response to or intolerance to UDCA.

 

Seladelpar is an orally administered drug that selectively acts on the peroxisome proliferator-activated receptor (PPAR) delta.

 

The drug demonstrated efficacy in the Phase III RESPONSE trial.

 

The RESPONSE trial was a randomized, double-blind, placebo-controlled trial evaluating the efficacy and safety of seladelpar versus placebo in adult PBC patients with an inadequate response to or intolerance of UDCA.

 

Results showed that 62% of the seladelpar group achieved the primary endpoint of composite biochemical response (improvement in ALP and total bilirubin levels) at 12 months, demonstrating statistically significant superiority compared to 20% in the placebo group.

 

Notably, 25% of the seladelpar treatment group achieved normalization of ALP, a meaningful clinical finding.

 

Seladelpar also showed benefit in the key secondary endpoint of pruritus improvement.

 

Among patients with moderate-to-severe pruritus at baseline, seladelpar reduced itch scores by 3.2 points at month 6, compared with 1.7 points in the placebo group, again demonstrating a statistically significant improvement.

 

Livdelzi received accelerated approval from the U.S.

 

FDA in August last year and was also approved in Europe in February this year.