Gilead Receives CHMP's Positive Opinion of Seladelpar to Treat Primary Biliary Cholangitis (PBC)
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- The CHMP has recommended Seladelpar + ursodeoxycholic acid (UDCA) to treat PBC in those with inadequate response or as monotx. in those intolerants to UDCA. The EC’s decision is expected in Q1’25
- Opinion was based on a P-III (RESPONSE) study assessing seladelpar (10mg, QD, oral) vs PBO in PBC patients (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)
- Gilead is also pursuing regulatory approval for seladelpar in regions beyond the EU & under review by the UK MHRA. It is a PPAR- δ agonist that blocks bile acid synthesis to treat PBC
Ref: Gilead | Image: Gilead
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