Neuren Pharmaceuticals (ASX:NEU) has announced that its partner Acadia Pharmaceuticals has received Health Canada approval for DAYBUE (trofinetide) for treating Rett syndrome in adult and pediatric patients two years of age.
In Canada, the prevalence of Rett syndrome is estimated to be 600 to 900 patients.
Neuren CEO Jon Pilcher said, “We are excited to see this first approval outside the United States, which is a significant milestone in the ongoing program to expand access to DAYBUE.”
Under Neuren’s agreement with Acadia, Canada is included in the North American region. Neuren said potential sales in Canada would be added to US sales to calculate its royalties and sales milestone payments.