Seladelpar

Gilead Sciences announces 81% of PBC patients achieve durable biochemical response with Livdelzi by Month 30, with 41% achieving ALP normalization. Livdelzi also reduces pruritus severity, with 27% near resolution in moderate to severe cases. The safety profile remains robust, with no treatment-related SAEs reported.

FDA denies full approval to Intercept's Ocaliva for primary biliary cholangitis (PBC), citing insufficient data. Ocaliva remains under accelerated approval since 2016. The decision aligns with a September AdCom meeting where 13 panel members found the data inadequate. Intercept plans to collaborate with the FDA for next steps.

FDA declined full approval for obeticholic acid (Ocaliva) in treating primary biliary cholangitis (PBC), citing unfavorable benefit-risk profile. Intercept Pharmaceuticals will collaborate with the FDA on next steps, while the drug remains on the market. European Commission revoked obeticholic acid's marketing authorization for PBC in September.

The FDA issued a Complete Response Letter to Intercept Pharmaceuticals’ obeticholic acid (Ocaliva) for primary biliary cholangitis (PBC), unable to approve its supplemental New Drug Application in its current form. The decision aligns with a negative opinion from a Gastrointestinal Drugs Advisory Committee meeting in September 2024, which found insufficient evidence to verify obeticholic acid’s benefits on clinical outcomes in PBC and its favorable benefit-risk profile. Despite the CRL, obeticholic acid remains available for PBC treatment under accelerated approval status in the US.

Gilead Sciences reported Q3 2024 revenue growth of 7% to $7.5 billion, with Biktarvy sales up 13% to $3.5 billion. Oncology sales rose 6% to $816 million. The company increased its full-year revenue, operating income, and EPS guidance. Product sales excluding Veklury grew 7% to $6.8 billion, driven by higher sales in HIV, Oncology, and Liver Disease.

Elafibranor received FDA accelerated approval for second-line PBC treatment, followed by seladelpar. ELFIDENCE, ELSPIRE, and ELFINITY trials assess elafibranor's efficacy and safety in PBC patients with compensated cirrhosis, incomplete UDCA response, and real-world settings, respectively.

Multinational pharma companies to showcase latest innovations at CIIE, including Teva's Austedo XR and Regro, Fosun Pharma's non-invasive device for tremor, and Gilead Sciences' Seladelpar for PBC.

FDA delays full approval for Intercept Pharmaceuticals' Ocaliva (obeticholic acid), originally due 15 October, pending further review. The drug, inherited by Alfasigma in 2023, faces setbacks including a 2018 FDA boxed warning and a 2024 advisory committee vote against full approval. Despite European Commission withdrawal and subsequent reinstatement, Ocaliva now competes with Gilead's Livdelzi and Ipsen's Iqirvo in the PBC treatment market.

FDA extends review of Intercept Pharmaceuticals' sNDA for full approval of obeticholic acid (Ocaliva) for primary biliary cholangitis (PBC), with no new action date provided. Despite a negative advisory committee opinion on its clinical outcomes and benefit-risk profile, Ocaliva remains available under accelerated approval.