Stoke Therapeutics announced that its request for an expedited filing of zorevunersen, a treatment for severe epilepsy, has been delayed by the Food and Drug Administration (FDA). In a statement released on Sunday, the company revealed that the FDA did not grant immediate approval following a meeting held in December 2023.
During the December meeting, the FDA indicated that while it was not dismissing Stoke’s request, further information is necessary before any decision can be made. The zorevunersen drug is specifically aimed at treating Dravet syndrome, a severe form of epilepsy that can lead to significant developmental challenges in children.
Stoke’s CEO, Ian Smith, shared insights into the discussions with the FDA during an interview. He noted that the agency has requested additional details concerning the ongoing Phase 3 study. This study is expected to conclude in mid-2027, which raises concerns about the timeline for zorevunersen’s potential availability to patients awaiting new treatment options.
The FDA’s request for more information does not completely close the door on an expedited submission. Stoke Therapeutics is actively working on gathering the necessary data and anticipates making a decision on the regulatory path for zorevunersen by mid-2024.
As the company moves forward, the focus remains on addressing the FDA’s requests to enhance the chances of securing a faster review process. The outcome of these discussions is crucial for Stoke, as it seeks to bring this potentially transformative treatment to market for patients suffering from Dravet syndrome.
The ongoing dialogue between Stoke and the FDA highlights the complexities of drug approval processes, particularly for treatments addressing rare and severe conditions. With continued collaboration, Stoke Therapeutics hopes to navigate these challenges effectively and provide new hope for patients and families affected by this debilitating disorder.
