Overview
- CHMP issued its negative opinion on 16 October 2025, and Sanofi says it will request a re-examination within the allowed window.
- The agency found it difficult to quantify benefit because the main study lacked an active comparator and allowed other concomitant treatments.
- An investigator-initiated first-line study was stopped early for lack of benefit, reinforcing doubts about effectiveness.
- A conditional marketing authorisation was considered but deemed unworkable since further effectiveness data are not expected before April 2030.
- Sanofi said current clinical trials and compassionate-use programs continue unchanged, and it notes the drug is approved in about 20 countries with more than 17,000 patients treated since 2021.