FDA Delays Stoke’s Request for Accelerated Approval of Epilepsy Drug

Stoke Therapeutics announced that it has not reached an agreement with the Food and Drug Administration (FDA) regarding an expedited submission for its treatment aimed at severe epilepsy. The company revealed this development on Sunday, following discussions that took place in December 2023.

The drug, known as zorevunersen, is specifically designed to treat Dravet syndrome, a severe form of epilepsy that primarily affects young children. During the recent meeting, FDA officials did not outright reject Stoke’s request to file for approval later this year. Instead, they requested additional information and indicated that further discussions are anticipated.

Stoke’s Chief Executive Officer, Ian Smith, shared insights during an interview, emphasizing that while the FDA has not closed the door on a potential expedited filing, the company must now provide more comprehensive data. The ongoing Phase 3 study of zorevunersen is set to conclude in mid-2027, and the additional information requested by regulators could influence the timeline for approval.

Looking ahead, Stoke aims to finalize its regulatory strategy for zorevunersen by mid-2024. The company remains optimistic about the discussions with the FDA and continues to prioritize the needs of those affected by Dravet syndrome.

As the situation develops, stakeholders in the pharmaceutical industry and advocacy groups are closely monitoring the progress of zorevunersen, as it holds potential for improving the lives of patients suffering from this debilitating condition.