Tiziana seeks FDA orphan drug designation for intranasal foralumab in multiple system atrophy
TLSA•Tiziana Life Sciences filed with the FDA for orphan drug designation for intranasal foralumab to treat multiple system atrophy. The drug is in a Phase 2a open-label trial, and the FDA typically reviews designation requests within 90 days.
1. Designation request filed
Tiziana Life Sciences filed with the FDA for orphan drug designation for intranasal foralumab to treat multiple system atrophy. The drug is being studied in a Phase 2a open-label trial at Brigham and Women’s Hospital under Mass General Brigham’s MyTrial program. The FDA typically reviews orphan designation requests within 90 days; a grant would confer incentives such as market exclusivity upon approval.
