Acadia: FDA Accepts New Drug Application for Trofinetide

 Acadia Pharmaceuticals Inc. said Monday the U.S. Food and Drug Administration accepted its new drug application of trofinetide for the treatment of Rett syndrome.

The FDA has granted a priority review and assigned a Prescription Drug User Fee Act action date of March 12, the biopharmaceutical company said. The FDA told Acadia that it isn't planning to hold an advisory committee meeting, the company said.

Trofinetide has already been granted fast track status and orphan drug designation for the treatment of Rett syndrome in the U.S. and the rare pediatric disease designation by the FDA.

Rett syndrome is a neurodevelopmental disorder that includes a period of normal development followed by regression with loss of language and hand function skills, impaired gait and development of hand stereotypes. It occurs worldwide in about one of every 10,000 to 15,000 female births, Acadia said.

The company has Nuplazid on the market to treat Parkinson's disease psychosis. Sales of the drug were $134.6 million in the three months ended June 30. Trofinetide is the next drug candidate in Acadia's pipeline.

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