Stoke Therapeutics has announced that the Food and Drug Administration (FDA) is not ready to approve an expedited submission for its treatment of severe epilepsy. The decision follows a meeting held in December 2023, where discussions centered around the company’s request to fast-track the filing of zorevunersen, a drug aimed at treating Dravet syndrome.
Ian Smith, CEO of Stoke Therapeutics, shared insights in an interview, indicating that while the FDA has not outright rejected the request, the agency has called for additional information. The FDA’s stance means that Stoke must continue its ongoing Phase 3 study, which is expected to conclude in the middle of 2027.
The FDA’s request for more data suggests a cautious approach to the approval process. The agency’s feedback provides Stoke with the opportunity to present further details that could support its case for zorevunersen. Smith noted that further discussions are on the horizon, which could shape the future regulatory path for the drug.
Stoke anticipates making a decision regarding its regulatory strategy for zorevunersen by the middle of this year. The company remains committed to addressing the needs of patients suffering from Dravet syndrome, a severe form of epilepsy that can lead to debilitating seizures and developmental delays.
As the situation unfolds, the pharmaceutical industry will be watching closely. The outcome of Stoke’s efforts could have significant implications not only for the company but also for the broader landscape of epilepsy treatment options.
