Acadia Says FDA Accepts For Filing NDA Of Trofinetide For Rett Syndrome Treatment

(RTTNews) - Acadia Pharmaceuticals Inc. (ACAD) said that the U.S. Food and Drug Administration has accepted for filing its New Drug Application (NDA) of trofinetide for the treatment of Rett syndrome.

The company noted that the FDA has granted a priority review and assigned a PDUFA or Prescription Drug User Fee Act action date of March 12, 2023. The FDA has also informed the company that at this time they are not planning to hold an Advisory Committee meeting.

Rett syndrome is a complex, multisystem neurodevelopmental disorder that includes a period of normal development followed by significant developmental regression with loss of language and hand function skills, impaired gait and development of hand stereotypes.

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