Neurotech International Ltd (ASX:NTI) Receives EMA Positive Opinion
Regulatory Milestone
Neurotech International Limited (ASX: NTI) announced that the European Medicines Agency (EMA) has issued a positive opinion on the company’s Orphan Medicinal Product Designation (OMPD) application for NTI164 to treat Rett Syndrome. The company submitted the OMPD in Europe in late October 2024 and expects the official decision from the European Commission soon.
Executive Comments
Dr Anthony Filippis, Chief Executive Officer & Managing Director of Neurotech, stated, “We are delighted to have received this positive opinion for orphan designation of NTI164 in Rett Syndrome for Europe. There are no approved therapies for Rett Syndrome in Europe, which remains a difficult to treat rare neurological disorder where safe and effective treatments are needed. In Europe, this represents a patient population of approximately 28,000 females. This positive opinion follows on from the US Food and Drug Administration (FDA) granting orphan designation for NTI164 in Rett Syndrome in late November 2024. Together with the US FDA orphan designation, the positive opinion from the EMA represents an important step towards this significant regulatory milestone for the company in Europe and positions NTI164 in Rett Syndrome for both the US and European markets.”
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