EU Court Upholds Withdrawal of Ocaliva's Conditional Approval
核心洞察
The EU General Court dismissed Advanz Pharma (搜索)'s challenge to the European Commission's 2024 decision revoking the conditional marketing authorisation for Ocaliva in primary biliary cholangitis (搜索).
The court held that a pending renewal application does not bar the Commission from completing a separate review where public-health grounds justify withdrawing a medicine.
Judges found no manifest error in CHMP's conclusion that the confirmatory trial 747-302 failed to establish clinical benefit, and rejected conflict-of-interest claims.
The General Court in Luxembourg has dismissed Advanz Pharma (搜索)'s challenge to the European Commission's 2024 decision to revoke the conditional marketing authorisation for Ocaliva (obeticholic acid) in primary biliary cholangitis (搜索) (PBC). The ruling, issued on 23 September, confirms that regulators may withdraw a conditionally approved medicine on public-health grounds without waiting for the outcome of a pending renewal application.
Ocaliva received its conditional authorisation in 2016 for PBC patients who cannot tolerate or do not respond adequately to ursodeoxycholic acid. Advanz acquired the authorisation in December 2022 and applied to convert it to a standard authorisation, but in October 2023 the EMA's Committee for Medicinal Products for Human Use concluded that the required confirmatory study, 747-302, had not demonstrated clinical benefit. Advanz filed a renewal application in May 2024; the CHMP concluded in June that efficacy had not been established and that the risk-benefit balance was unfavourable, and the Commission revoked the approval in August 2024.
The court rejected Advanz's argument that a valid renewal application had to keep the approval in place until the Commission decided on it, holding that the renewal provision was intended to prevent administrative removal from the market rather than to block regulatory action. It found no manifest error in the CHMP's decision to weight the randomised, double-blind, placebo-controlled trial above real-world evidence and post-hoc analyses, and rejected allegations of procedural flaws and a conflict of interest in the EMA's ad hoc expert consultation. Patient group CBP Portugal had intervened in support of Advanz.
Read the full report at ICLG.