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# FDA Won’t Review Toriluzole NDA
- URL: https://www.fdaweb.com/fda-wont-review-toriluzole-nda/
- Published: 2023-07-27T12:00:00.000Z
- Updated: 2026-09-14T18:46:54.000Z
- Author: David McFarland
- Tags: Drugs, #legacy-id-D5154969

FDA has told BioHaven that it will not review the company’s NDA for toriluzole to treat spinocerebellar ataxia because a Phase 3 study failed to meet its primary endpoint and thus the agency cannot perform a substantive review. The company [says](https://ir.biohaven.com/news-releases/news-release-details/biohaven-provides-preliminary-eeg-data-update-kv7-platform?ref=fdaweb.com) it is requesting a Type A meeting with FDA officials to address the concerns in the refusal-to-file letter. BioHaven says it is committed to working with the agency as quickly as possible to bring toriluzole to patients since there is no approved therapy for this ultra-rare disease.