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News

US FDA Grants Accelerated Approval to Gilead’s Livdelzi (Seladelpar) to Treat Primary Biliary Cholangitis (PBC) 

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  • Gilead’s Livdelzi (Seladelpar) as monotx. or in combination with ursodeoxycholic acid (UDCA) has received accelerated approval for adults unable to tolerate UDCA or with inadequate response to UDCA, respectively. Not recommended for individuals with decompensated cirrhosis 
  • The approval was based on a P-III (RESPONSE) study showing 62% vs 20% (Livdelzi vs PBO) composite biochemical response at 12mos.; normalization of ALP value in 25% Livdelzi pts at 12mos. 
  • For complete approval, confirmatory long-term study P-III (AFFIRM) has been initiated to evaluate Livdelzi’s effect in compensated cirrhosis patients due to PBC. Seladelpar’s review has been accepted by MHRA and EMA

Ref: Businesswire | Image: Gilead| Press Release

Related News:- Galderma Reports the US FDA’s Approval of Nemluvio (Nemolizumab) for Treating Prurigo Nodularis (PN) 

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