RegulatoryApr 27, 2026, 01:06 PM
SNY Tzield, Dupixent US Approved; Cenrifki EU Recommended
AI Summary
Sanofi announced significant regulatory milestones, including US FDA approvals for Tzield to delay stage 3 type 1 diabetes in young children and for Dupixent (with Regeneron) as the first biologic for young children with uncontrolled chronic spontaneous urticaria. Additionally, the CHMP recommended EU approval for Cenrifki (tolebrutinib) for secondary progressive multiple sclerosis without relapses. The company also provided an update on the Sarclisa subcutaneous regulatory submission in the US and reported positive tolerability data for its Nuvaxovid COVID-19 vaccine.
Key Highlights
- US FDA approved Tzield to delay stage 3 type 1 diabetes onset in young children.
- US FDA approved Dupixent (with Regeneron) for young children with uncontrolled chronic spontaneous urticaria.
- CHMP recommended EU approval for Cenrifki (tolebrutinib) for secondary progressive multiple sclerosis without relapses.
- Sanofi provided an update on the Sarclisa subcutaneous regulatory submission in the US.
- Sanofi's Nuvaxovid COVID-19 vaccine showed better tolerability than mNEXSPIKE in a head-to-head study.