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
Related Post:- Acadia Reports the NDA Submission of Trofinetide to the US FDA for the Treatment of Rett Syndrome
Click here to read the full press release
Neha is a Senior Editor at PharmaShots. She is passionate and very enthusiastic about recent updates and developments in the life sciences and pharma industry. She covers Biopharma, MedTech, and Digital health segments along with different reports at PharmaShots. She can be contacted at [email protected].