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
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