Stoke Therapeutics has announced that its request for an expedited submission of the epilepsy treatment zorevunersen has not been approved by the Food and Drug Administration (FDA). The company revealed this outcome following a meeting held in December 2023 with FDA officials, highlighting ongoing discussions about the potential regulatory path for the drug.
Ian Smith, CEO of Stoke Therapeutics, stated in an interview that while the FDA did not outright decline the request, they emphasized the need for additional information before making a final decision. The drug in question is aimed at treating Dravet syndrome, a severe form of epilepsy that poses significant challenges for affected individuals and their families.
Regulatory Path Forward
Stoke’s initial request was to allow for the submission of zorevunersen before the completion of an ongoing Phase 3 clinical trial, which is expected to conclude in the middle of 2027. The FDA’s response indicates a willingness to consider the submission later this year, contingent upon the provision of further data.
The ongoing discussions aim to clarify the information required by regulators, and Stoke is optimistic about defining its regulatory strategy for zorevunersen by mid-year. The company is focused on addressing the needs of patients suffering from Dravet syndrome, who often experience debilitating seizures and require effective treatment options.
With the FDA’s decision pending, stakeholders in the pharmaceutical and healthcare sectors will be closely monitoring developments related to Stoke Therapeutics and its promising epilepsy treatment. The outcome of this situation could significantly impact the future of zorevunersen and its potential to improve the lives of those affected by severe epilepsy.
