Tiziana Life Sciences seeks FDA orphan drug status for nasal MSA therapy
Tiziana Life Sciences has submitted a request to the US Food and Drug Administration seeking orphan drug designation for its intranasal foralumab, a candidate therapy for multiple system atrophy (MSA), a rare neurodegenerative disease that currently has no approved disease-modifying treatments. MSA is a rapidly progressive disorder affecting autonomic and motor functions.
Why it matters — Obtaining orphan drug designation could offer regulatory advantages for Tiziana's intranasal foralumab and signal progress in addressing an unmet medical need in a rare disease.