Biohaven Ltd. (NYSE: BHVN) announced the Food and Drug Administration no longer plans to hold an advisory committee meeting for its troriluzole drug application.
The FDA's Division of Neurology 1 communicated the decision on August 21, according to the company's statement. The division previously indicated in May it would convene an advisory committee to discuss the New Drug Application for troriluzole, intended to treat adult patients with Spinocerebellar Ataxia.
The FDA extended the Prescription Drug User Fee Act date for the application by three months in May to allow time for review of the company's recent submissions responding to agency information requests. The regulatory decision timeline remains unchanged, with the FDA expected to make a determination during the fourth quarter of 2025.
Spinocerebellar Ataxia is a group of hereditary neurological disorders that affect movement and coordination. Troriluzole is being developed as a potential treatment for adult patients with the condition.
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