Primary biliary cholangitis is a potentially life-threatening autoimmune disease of the liver. ALP is a marker of cholestasis and can predict the risk of liver transplantation and death.
According to the news from the Futubull app, Gilead Sciences (GILD.US) announced that the FDA has accelerated the approval of Livdelzi (seladelpar) in combination with ursodeoxycholic acid (UDCA) for the treatment of primary biliary cholangitis (PBC) in adult patients who are unresponsive to UDCA or as monotherapy for patients who are intolerant to UDCA, but Livdelzi is not recommended for patients with or at risk for decompensated cirrhosis. According to the press release, Livdelzi is the first therapy to demonstrate statistically significant improvement compared to placebo in alkaline phosphatase (ALP) normalization, key biomarkers, and itch control. Currently, the UK Medicines and Healthcare Products Regulatory Agency (MHRA) and the European Medicines Agency (EMA) are evaluating the application for the marketing authorization of Livdelzi.
Primary biliary cholangitis is a potentially life-threatening autoimmune liver disease. ALP is a cholestasis marker that can predict the risk of liver transplantation and death.
Livdelzi is an oral, potent and selective peroxisome proliferator-activated receptor δ (PPARδ) agonist. PPARδ is expressed in multiple cell types in the liver, and preclinical data suggest that it regulates multiple genes involved in bile acid synthesis, inflammation, and fibrosis. The drug was granted breakthrough therapy designation by the FDA in February 2019 for the treatment of PBC. The therapy was originally developed by CymaBay and was acquired by Gilead Sciences in February 2024 for a total amount of $4.3 billion.