Gilead Sciences advances toward EU approval for seladelpar in PBC treatment, showing impressive 62% response rate and significant symptom improvements in clinical trials.

In a flurry of decisions Friday, the European Medicines Agency’s human products committee recommended 17 new drugs for approval while letting Takeda withdraw from market an inflammatory bowel disea | ...

Majority of patients achieve meaningful pruritus relief, according to long-term ASSURE data

Primary biliary cholangitis (PBC) is a chronic cholestatic liver disease characterized by autoimmune-mediated destruction of intrahepatic bile ducts, leading to fibrosis, cirrhosis, and liver failure. Ursodeoxycholic acid remains the first-line treatment, but up to 40% of patients respond inadequately and continue to experience fatigue and pruritus. This therapeutic gap has recently been addressed by the approval of two new drugs, elafibranor and seladelpar, which activate peroxisome proliferator-activated receptors (PPARs). This review explores recently unveiled molecular mechanisms underlying the effectiveness of PPAR-targeting drugs in PBC, focusing on their effects on cellular immune regulation, bile acid production and toxicity, and hepatic fibrosis. Additionally, we examine current knowledge and ongoing challenges that will influence the roles of PPAR agonists in improving PBC treatment.

Primary biliary cholangitis (PBC) is a chronic cholestatic liver disease characterized by autoimmune-mediated destruction of intrahepatic bile ducts, leading to fibrosis, cirrhosis, and liver failure. Ursodeoxycholic acid remains the first-line treatment, but up to 40% of patients respond inadequately and continue to experience fatigue and pruritus. This therapeutic gap has recently been addressed by the approval of two new drugs, elafibranor and seladelpar, which activate peroxisome proliferator-activated receptors (PPARs). This review explores recently unveiled molecular mechanisms underlying the effectiveness of PPAR-targeting drugs in PBC, focusing on their effects on cellular immune regulation, bile acid production and toxicity, and hepatic fibrosis. Additionally, we examine current knowledge and ongoing challenges that will influence the roles of PPAR agonists in improving PBC treatment.

SMC decision expands options for people with chronic itch

Identifying off-target interactions of approved drugs is important to anticipate side effects and uncover repurposing opportunities. Computational pipelines combining structural homology, structure pr...

Gilead Sciences just hit Korea’s accelerator with Livdelzi (seladelpar) -- and Ipsen’s rival Iqirvo (elafibranor) may be inching toward the line, too, according to a local report -- injecting rivalry into a rare-liver field that barely stirred a year ago.The Ministry of Food and Drug Safety (MFDS) o

Gilead Sciences just hit Korea’s accelerator with Livdelzi (seladelpar) -- and Ipsen’s rival Iqirvo (elafibranor) may be inching toward the line, too, according to a local report -- injecting rivalry into a rare-liver field that barely stirred a year ago.The Ministry of Food and Drug Safety (MFDS) o

Gilead Sciences just hit Korea’s accelerator with Livdelzi (seladelpar) -- and Ipsen’s rival Iqirvo (elafibranor) may be inching toward the line, too, according to a local report -- injecting rivalry into a rare-liver field that barely stirred a year ago.The Ministry of Food and Drug Safety (MFDS) o

Gilead Sciences just hit Korea’s accelerator with Livdelzi (seladelpar) -- and Ipsen’s rival Iqirvo (elafibranor) may be inching toward the line, too, according to a local report -- injecting rivalry into a rare-liver field that barely stirred a year ago.The Ministry of Food and Drug Safety (MFDS) o

(Adnkronos) - L'Agenzia italiana del farmaco (Aifa) ha approvato il rimborso di seladelpar per il trattamento della colangite biliare primitiva (Primary Biliary Cholangitis, Pbc) in combinazione con acido ursodesossicolico (Udca) negli adulti che hanno una risposta inadeguata al solo Udca o in monoterapia nei casi in cui Udca non è tollerato. Lo annuncia Gilead Sciences