The Food and Drug Administration (FDA) has postponed its decision regarding Stoke Therapeutics’ request for an expedited filing of its drug intended for severe epilepsy treatment. The company announced this development on Sunday, following a meeting held in December 2023.
During the discussions, the FDA did not completely dismiss Stoke’s proposal to submit zorevunersen, a treatment specifically targeting Dravet syndrome, before the conclusion of its ongoing Phase 3 study, which is expected to wrap up in the middle of 2027. Ian Smith, the CEO of Stoke, shared insights about the meeting in an interview, emphasizing that regulators have requested additional information before moving forward.
The FDA’s cautious stance reflects its ongoing commitment to ensuring that all necessary data is reviewed thoroughly. Further discussions between the agency and Stoke are anticipated as both parties work toward a definitive regulatory path for zorevunersen.
Stoke plans to reach a decision regarding its regulatory approach to zorevunersen by the middle of this year. The outcome of these discussions could impact the timeline for bringing this potentially life-changing treatment to patients suffering from Dravet syndrome, a severe form of epilepsy that often manifests in early childhood.
As Stoke navigates this regulatory landscape, the company remains hopeful about the prospects of zorevunersen. The treatment aims to provide relief for patients who often face limited options and challenging outcomes from existing therapies.
In the coming months, the healthcare community will be watching closely as Stoke and the FDA continue their dialogue, potentially paving the way for faster access to this innovative treatment for those affected by Dravet syndrome.
