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Fast Track Designation Approval and Orphan Drug Designation Request for Intranasal Foralumab in the Treatment of Non-...


Published / Modified Jun 11 2024
CSIMarket Team / CSIMarket.com





In recent news, Tiziana Life Sciences has achieved a significant milestone in its pursuit of developing innovative immunomodulation therapies for various diseases, particularly non-active, secondary-progressive multiple sclerosis (na-SPMS). The biotechnology company has successfully obtained Fast Track Designation approval from the U.S. Food and Drug Administration (FDA) for its intranasal foralumab treatment. Furthermore, Tiziana has also submitted a request to obtain Orphan Drug Designation for the same therapy, aiming to provide a groundbreaking solution for na-SPMS patients.

The Fast Track Designation approval signifies the FDA's recognition of the urgent need for effective treatment options for individuals suffering from na-SPMS. Tiziana's intranasal foralumab aims to address this unmet medical need by leveraging innovative routes of drug delivery. By securing Fast Track Designation, Tiziana can expedite the development and review process of this therapy, potentially accelerating its availability to patients in need.

Additionally, Tiziana's request for Orphan Drug Designation for intranasal foralumab for the treatment of na-SPMS highlights the company's commitment to tackling this specific form of multiple sclerosis. If approved, foralumab would be the first therapy to receive such designation for na-SPMS. The submission is supported by clinical and non-clinical evidence, including data from the Brigham & Women's Hospital longitudinal study and the CLIMB study, which estimated the prevalence of na-SPMS in the population.

Excitingly, Tiziana has also shared updated clinical and PET scan findings, showcasing the positive impact of intranasal foralumab treatment in multiple sclerosis patients. Six out of eight Intermediate Size Patient Population Expanded Access (EA) patients demonstrated improvements in fatigue scores measured by the Modified Fatigue Impact Scale (MFIS). Moreover, PET scan findings portrayed a reduction in microglial activation in these six patients with MFIS score improvement after three months of treatment. Two additional EA patients' PET scan results are eagerly awaited and expected to be available in late January, contributing further to the growing body of evidence supporting the efficacy of intranasal foralumab.

Overall, Tiziana Life Sciences' achievements in obtaining Fast Track Designation approval and progressing towards Orphan Drug Designation for intranasal foralumab in the treatment of na-SPMS exemplify significant advancements in the field of immunomodulation therapies. These milestones reflect the company's dedication to addressing the unmet needs of patients living with non-active, secondary-progressive multiple sclerosis, potentially revolutionizing treatment options for this specific population.







Sources for this article: Tiziana Life Sciences Ltd Press release, News Wire, Globe Newswire, Business wire, Pr newswire.... and CSIMarket.com Customer Analytics Research for Tiziana Life Sciences Ltd






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