Posted by Michael Wonder on 18 Jul 2022
Acadia Pharmaceuticals submits new drug application to the U.S. FDA for trofinetide for the treatment of Rett syndrome
18 July 2022 - Acadia Pharmaceuticals today announced that the company has submitted a new drug application to the U.S. FDA for trofinetide for the treatment of Rett syndrome in adults and paediatric patients two years of age and older.
The new drug application submission is supported by results from the pivotal Phase 3 Lavender study evaluating the efficacy and safety of trofinetide versus placebo in 187 girls and young women aged 5-20 years with Rett syndrome.
