Stoke Therapeutics announced that it has not reached an agreement with the Food and Drug Administration (FDA) regarding a faster submission process for its treatment of severe epilepsy. The company revealed this update on March 24, 2024, following discussions that took place in December 2023. The FDA did not completely dismiss Stoke’s request for an expedited filing of zorevunersen, a treatment specifically targeting Dravet syndrome, which is a rare and severe form of epilepsy.
During the meeting, the FDA expressed the need for additional information before making a decision on the regulatory path for zorevunersen. According to Stoke’s CEO, Ian Smith, the regulatory body has not ruled out the possibility of allowing the company to file later this year, rather than waiting for the conclusion of the ongoing Phase 3 clinical study, which is scheduled to complete in mid-2027.
Stoke Therapeutics is in the process of compiling the requested data and anticipates engaging in further discussions with the FDA. Smith indicated that the company aims to finalize its regulatory strategy for zorevunersen by mid-2024. This timeline is critical for patients suffering from Dravet syndrome, who are in need of effective treatment options.
The ongoing Phase 3 trial of zorevunersen is designed to evaluate the drug’s safety and efficacy in a larger population of patients. Success in this trial is essential for the potential approval of the treatment. The FDA’s decision-making process typically involves a thorough review of clinical trial data, which can significantly impact the availability of new therapies for patients.
Stoke Therapeutics has been at the forefront of developing innovative treatments for severe genetic epilepsies. The company’s focus on zorevunersen reflects a commitment to addressing unmet medical needs in this challenging area of healthcare.
As the situation develops, stakeholders in the epilepsy community, including patients and healthcare providers, will be closely monitoring the interactions between Stoke and the FDA. The outcome of these discussions could reshape the treatment landscape for individuals affected by Dravet syndrome and similar conditions.
