INTELLIGENCE OVERVIEW
Agency: European Medicines Agency (EMA)
Product: Sanofi – New medicinal product
Indication: Chronic graft-versus-host disease (cGVHD)
Procedure: Centralised
Status: Positive CHMP opinion
Date of Publication: 30-Jan-2026
The EMA’s Committee for Medicinal Products for Human Use (CHMP) has issued a positive opinion recommending approval of a Sanofi-developed medicine for the treatment of chronic graft-versus-host disease in patients with an inadequate response to prior systemic therapies.
The recommendation is based on a favourable benefit–risk assessment, demonstrating clinically meaningful efficacy in a condition with significant unmet medical need.
The final marketing authorisation decision will be taken by the European Commission, following which the product may be marketed across the European Union.
https://www.ema.europa.eu/en/news/new-medicine-treat-chronic-graft-versus-host-disease