Iqirvo (elafibranor) di Ipsen ha ottenuto la Conditional Marketing Authorization da EMA per il trattamento della PBC in 2 Linea

On Sept 20, 2024, Ipsen's Iqirvo (elafibranor) received conditional marketing authorization in the European Union for 2L PBC. 

The EMA-approved indication is consistent with the Iqirvo USPI. However, the Iqirvo SmPC has several key differences vs Iqirvo USPI, which are overall favorable for Iqirvo in EU, such as:

• Less stringent language around hepatic safety / use in hepatic impairment
• Pruritis data is included in SmPC, including exploratory endpoints (vs. no pruritis data in USPI)
• Overall fewer safety warnings and more liberal DDI language vs USPI, eg:
  • No mention of fractures in SmPC (vs. Warning & Precaution in USPI: “Fractures occurred in 6% of Iqirvo-treated patients compared to no placebo-treated patients”)
  • No discussion of increased risk of myopathy with statin use, except in patient leaflet (USPI lists Statin-Iqirvo DDI in the Drug Interactions section)

Press Release

https://www.ema.europa.eu/en/medicines/human/EPAR/iqirvo