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# Troriluzole PDUFA Action Date Extended
- URL: https://www.fdaweb.com/troriluzole-pdufa-action-date-extended/
- Published: 2025-05-15T12:00:00.000Z
- Updated: 2026-09-14T15:11:58.000Z
- Author: David McFarland
- Tags: Drugs, #legacy-id-D5159185

FDA has extended by three months the PDUFA action date for Biohaven’s troriluzole to treat the rare disease spinocerebellar ataxia. A company [statement](https://ir.biohaven.com/news-releases/news-release-details/fda-extends-pdufa-date-biohavens-troriluzole-nda-rare-disease?ref=fdaweb.com) says an agency decision is now expected in the fourth quarter of 2025.

According to the company, FDA did not raise any new concerns in its letter and said the delay was needed to provide time for a full review of Biohaven’s submissions in response to agency information requests. FDA also indicated it plans to convene an advisory committee to discuss the Biohaven NDA.

Troriluzole is described as a new chemical entity and a third-generation novel prodrug that modulates glutamate. Biohaven has been granted an FDA orphan drug designation and priority review for the indication being studied.