Stoke Therapeutics announced that it has not reached an agreement with the Food and Drug Administration (FDA) regarding an expedited submission for its severe epilepsy treatment, zorevunersen. The company revealed this development on Sunday, following discussions with the FDA that took place in December.
During the meeting, the FDA did not outright deny Stoke’s request to permit an earlier filing of zorevunersen, which targets Dravet syndrome. Instead, regulators requested additional information from the company and indicated that further discussions will occur. According to Stoke’s CEO, Ian Smith, the FDA’s response suggests that there is still potential for the treatment’s submission to occur later this year, rather than waiting for the completion of an ongoing Phase 3 study expected in mid-2027.
Future Steps and Expectations
Stoke Therapeutics is now focused on gathering the necessary data to support its application. The company aims to finalize its regulatory strategy for zorevunersen by the middle of the year. This timeline reflects Stoke’s commitment to bringing the treatment to patients as quickly as possible, pending regulatory approval.
Zorevunersen has the potential to significantly impact the lives of patients suffering from Dravet syndrome, a severe form of epilepsy characterized by frequent seizures. As the company prepares for upcoming discussions with the FDA, stakeholders remain hopeful about the prospects of this promising treatment.
The ongoing dialogue with the FDA highlights the complexities of the drug approval process, particularly for conditions that currently have limited treatment options. Stoke’s proactive approach and readiness to provide additional information could play a crucial role in expediting zorevunersen’s path to market, ultimately benefiting those in need of new therapies for severe epilepsy.
As developments unfold, the company is committed to transparency and will keep the public informed about its regulatory pathway and the anticipated timeline for zorevunersen.
