Gilead Receives EC’s Conditional Marketing for Seladelpar to Treat Primary Biliary Cholangitis (PBC)
Shots:
- Following the MHRA approval (Jan 2025), the EC has granted conditional MAA to Seladelpar +/- ursodeoxycholic acid (UDCA) to treat PBC in those with inadequate response or intolerants to UDCA, respectively; ongoing regulatory review in Canada and Australia
- MAA was based on a worldwide P-III (RESPONSE) study assessing seladelpar (10mg, QD, oral) vs PBO in PBC pts (n=193). It showed composite biochemical response in 62% vs 20% & ALP normalization of 25% at 12mos. (1EP) plus pruritus reduction of 3.2 vs 1.7 points at 6mos. (2EP)
- Seladelpar (oral) is a PPAR- δ agonist that blocks bile acid synthesis to treat PBC
Ref: Gilead | Image: Gilead
Related News:- Gilead Reports US FDA’s NDA Acceptance of Lenacapavir for Pre-Exposure Prophylaxis (PreP) to Prevent HIV in Individuals at Risk
PharmaShots! Your go-to media platform for customized news ranging for multiple indications. For more information connect with us at connect@pharmashots.com
Click here to read the full press release
Tags
A passionate content writer with expertise in delivering high-quality and engaging content, Dipanshu is a keen reader and a versatile writer. Dipanshu dedicatedly covers news ranging from biopharma, life sciences, biotech, and MedTech to diagnostics and animal health companies, FDA, EMA, and biosimilar approvals. He can be contacted at connect@pharmashots.com
