Shire receives fast-track designation from FDA for SHP609 in Hunter syndrome
Ireland-headquartered drugmaker Shire (LSE: SHP) has received fast-track designation from the US Food and Drug Administration for its SHP609 (idursulfase-IT).
The designation has been granted for the treatment of neurocognitive decline associated with Hunter syndrome.
This investigational formulation of idursulfase has been designed for direct administration into the cerebrospinal fluid via an intrathecal drug delivery device. The formulation is being investigated and developed for use with Elaprase (idursulfase), Shire’s Hunter syndrome treatment that has already been approved.
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