Acadia’s Daybue (trofinetide) Receives the US FDA’s Approval for Rett Syndrome in Adult and Pediatric Patients Aged ≥2Years
- The US FDA has approved Daybue for the treatment of Rett syndrome in adult and pediatric patients aged ≥2yrs. The product is expected to be available in the US at the end of April 2023
- The approval was based on the results from the P-III study (LAVENDER) evaluating trofinetide vs PBO in 187 female patients aged 5-20yrs. which showed an improvement on both co-primary efficacy EPs as measured by the change from baseline in RSBQ total score and the Clinical Global Impression-Improvement (CGI-I) scale score @12wks.
- Acadia & Neuren Pharmaceuticals collaborated in 2018 for the development and commercialization of trofinetide to treat Rett syndrome and other indications in North America
Ref: Acadia | Image: Acadia
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