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July 18, 2022 - 4:07 pm
SAN DIEGOAcadia Pharmaceuticals Inc. (Nasdaq: ACAD) today announced that the company has submitted a New Drug Application (NDA) to the U.S. Food and Drug Administration (FDA) for trofinetide for the treatment of Rett syndrome in adults and pediatric patients two years of age and older.
“This is an important step forward for members of the Rett community who face a devastating disease with no approved therapies,” said Steve Davis, Chief Executive Officer. “We are grateful to the patients, their families and the physicians who have participated in the trofinetide clinical studies, including our pivotal Phase 3 Lavender study. We look forward to working with the FDA as it evaluates the NDA.”
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