Stoke Therapeutics announced that the Food and Drug Administration (FDA) has postponed its decision regarding an expedited application for the company’s treatment for severe epilepsy. This setback follows a meeting in December 2023, where officials discussed the potential for Stoke to file for approval of zorevunersen, a drug aimed at treating Dravet syndrome, before the conclusion of an ongoing Phase 3 clinical study scheduled for mid-2027.
During an interview, Stoke’s CEO Ian Smith revealed that while the FDA did not outright reject the request, the agency has requested additional information before moving forward. This indicates that there is still a possibility for Stoke to submit its application later this year, depending on the outcome of forthcoming discussions with regulators.
Stoke Therapeutics is now focusing on providing the necessary data to satisfy the FDA’s requirements. The company aims to finalize its regulatory strategy for zorevunersen by mid-2024, as it navigates through the complexities of drug approval processes.
The potential approval of zorevunersen is significant for patients suffering from Dravet syndrome, a severe form of epilepsy that often leads to life-threatening seizures. The urgency surrounding this treatment underscores the importance of timely access to effective therapies for those affected.
As Stoke prepares its next steps, the outcome of these discussions with the FDA could have considerable implications not only for the company but also for the broader epilepsy treatment landscape. Stakeholders will be closely monitoring the situation as new information emerges.
