Posted by Michael Wonder on 09 Jan 2025
Denali Therapeutics announces US FDA breakthrough therapy designation granted to tividenofusp alfa for the treatment of Hunter syndrome
8 January 2025 - Denali Therapeutics today announced that the US FDA has granted breakthrough therapy designation for tividenofusp alfa (DNL310) for the treatment of individuals with Hunter syndrome (MPS II).
This designation is in addition to fast track designation, orphan drug designation and rare paediatric disease designation, all previously granted by the FDA for tividenofusp alfa in Hunter syndrome.
