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Acadia Reports the NDA Submission of Trofinetide to the US FDA for the Treatment of Rett Syndrome

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Acadia Reports the NDA Submission of Trofinetide to the US FDA for the Treatment of Rett Syndrome

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  • 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

Click here to­ read the full press release 

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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 connect@pharmashots.com.

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