Neurotech International's FDA Response on Orphan Drug Request

Neurotech International Limited (ASX:NTI) has received a response from the US Food and Drug Administration (FDA) regarding the request for orphan drug designation (ODD) for the use of NTI164 in Paediatric Autoimmune Neuropsychiatric Disorders Associated with Streptococcal Infections (PANDAS) and Paediatric Acute-Onset Neuropsychiatric Syndrome (PANS). The FDA has declined the orphan drug status and granted Neurotech a 12-month abeyance to address the agency's objections.

Neurotech International's Executive Commentary

The FDA's decision to decline the orphan drug status for NTI164 in PANDAS/PANS does not impact Neurotech's development plans for the disorder. The company remains committed to addressing the urgent need for new therapies in the absence of approved treatments. Neurotech will consider providing a response to the FDA in the months ahead, in consultation with its regulatory advisors. Additionally, the Company is expecting the outcome of another orphan drug designation request for NTI164 with the US FDA for Rett Syndrome before December 2024.

Neurotech International's FDA Response Summary

The US FDA has declined Neurotech International's request for orphan drug designation for NTI164 in PANDAS/PANS, citing concerns about the prevalence of the disorder in the United States. Despite this decision, Neurotech's development plans for PANDAS/PANS remain unaffected, supported by strong clinical data and evidence of NTI164's efficacy. The Company will continue to work towards addressing the urgent need for new therapies in the absence of approved treatments. Neurotech also anticipates the outcome of another orphan drug designation request for NTI164 with the US FDA for Rett Syndrome before December 2024. The Company aims to provide valuable insights into PANDAS/PANS and seek global consensus for the disorder through its clinical advisory group and ongoing research efforts.