FDA Delays Decision on Biohaven’s Troriluzole for Rare Disease, Plans Advisory Committee Review

The FDA has extended its decision date for Biohaven's new drug application (NDA) for troriluzole, intended to treat spinocerebellar ataxia (SCA), by three months to allow further review of recent submissions from the company45.

The decision on approval is now expected in the fourth quarter of 2025235.

The FDA plans to hold an advisory committee meeting (adcomm) to discuss the application, but a date has not been scheduled yet5.

No new concerns were raised by the FDA in its communications about the delay5.

Troriluzole has received Fast-Track, Orphan Drug Designation, and Priority Review for SCA, a rare and life-threatening neurodegenerative disorder with no FDA-approved treatments currently available5.

Clinical data show that troriluzole may slow SCA disease progression by 50-70% and reduce the risk of falls5.

Biohaven recently completed the FDA mid-cycle review meeting and regulatory inspections relevant to the application5.

Sources:

2. https://ir.biohaven.com/news-releases/news-release-details/fda-extends-pdufa-date-biohavens-troriluzole-nda-rare-disease

3. https://endpts.com/biohaven-stock-sinks-on-three-month-delay-for-neuro-drug-fda-approval-decision/

4. https://www.pharmalive.com/fda-delays-decision-date-on-biohavens-spinocerebellar-ataxia-application/

5. https://www.marketscreener.com/quote/stock/BIOHAVEN-LTD-144171176/news/Fda-Extends-Pdufa-Date-of-Biohaven-s-Troriluzole-Nda-for-Rare-Disease-Spinocerebellar-Ataxia-49957394/