Acadia Reports the NDA Submission of Trofinetide to the US FDA for the Treatment of Rett Syndrome
Shots:
- The NDA submission was based on the P-III (Lavender) study evaluating the efficacy and safety of trofinetide vs PBO in 187 girls and young women aged 5-20yrs. with Rett syndrome
- The study showed a statistically significant improvement in the co-primary EPs i.e., RSBQ change from baseline to 12wks. and CGI-I scale score @12wks. The study also met its key 2EPs i.e., CSBS-DP-IT–Social change from baseline to 12wk.
- Acadia & Neuren collaborated to develop and commercialize trofinetide for the treatment of Rett syndrome and other indications in North America. Trofinetide has received FTD & ODD for Rett syndrome in the US & RPD designation from the US FDA
Ref: Bussinesswire | Image: Acadia
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