Posted: 1 May 2024
Neuren Pharmaceuticals (ASX: NEU) is pleased to report that Health Canada has accepted for review the New Drug Submission (NDS) of trofinetide for the treatment of Rett syndrome, that was submitted by Neuren’s global partner Acadia Pharmaceuticals (Nasdaq: ACAD). Health Canada has granted a Priority Review for the submission. The NDS is supported by results from the positive pivotal Phase 3 LAVENDER™ study evaluating the efficacy and safety of trofinetide versus placebo in 187 girls and young women with Rett syndrome.
The announcement released by Acadia is attached.
Acadia estimates there are 600 to 900 Rett syndrome patients in Canada. Trofinetide has been approved for the treatment of Rett syndrome in adult and pediatric patients two years of age and older in the United States, and it is not currently authorised for sale in Canada for the treatment of Rett syndrome.
Acadia has exclusive rights to develop and commercialize trofinetide globally. Under the terms of Neuren’s agreement with Acadia, the development and commercialisation of trofinetide is fully funded by Acadia. Canada is included as part of the North America region under Neuren’s agreement with Acadia. If marketing authorisation is granted by Health Canada, any potential sales of trofinetide in Canada will be combined with sales in the US for the purpose of determining Neuren’s entitlement to milestone payments and royalties.
