Tiziana seeks orphan status for foralumab

• Tiziana Life Sciences (NASDAQ:TLSA) requested FDA Orphan Drug Designation for intranasal foralumab in multiple system atrophy.
• The designation, if granted and followed by approval, could provide seven years of market exclusivity and other regulatory benefits.
• Tiziana is evaluating foralumab in a six-month Phase 2a trial using PET imaging and clinical assessments.

Tiziana Life Sciences (NASDAQ:TLSA) submitted a request to the U.S. Food and Drug Administration for Orphan Drug Designation for intranasal foralumab as a potential treatment for multiple system atrophy (MSA).

MSA is a rare progressive disorder affecting autonomic functions and motor control, and there are currently no FDA-approved disease-modifying therapies for the condition.

If granted, the FDA orphan designation could provide benefits including seven years of market exclusivity following approval, qualified clinical-testing tax credits, certain application-fee waivers and eligibility for protocol assistance.

Tiziana is evaluating intranasal foralumab in a six-month Phase 2a open-label trial at Brigham and Women’s Hospital in Boston, with the study assessing microglial activation through PET imaging alongside clinical outcomes and safety measures.

The FDA Office of Orphan Products Development aims to review orphan designation requests within 90 days of receipt, while Tiziana’s foralumab program remains under clinical evaluation.