Tiziana Life Sciences, Ltd. (TLSA) Wednesday said it received Fast Track designation from the Food and Drug Administration or FDA for its intranasal formulation of foralumab, a fully human anti-CD3 monoclonal antibody, for the treatment of non-active Secondary Progressive Multiple Sclerosis (na-SPMS).
The Fast Track designation provides several benefits, including more frequent meetings with the FDA to discuss the drug's development plan, eligibility for Accelerated Approval and Priority Review if relevant criteria are met, and a potential Rolling Review of the New Drug Application (NDA).
Currently, 10 patients with na-SPMS have been dosed in an Expanded Access (EA) Program with either an improvement or stability of disease seen within 6 months in all patients. Additionally, intranasal foralumab is currently being studied in a Phase 2a study in patients with na-SPMS.
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