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

Stoke Therapeutics announced that its request for an expedited filing of a treatment for severe epilepsy has been delayed by the Food and Drug Administration (FDA). The company, based in San Francisco, reported on Sunday that discussions with the FDA did not result in an agreement to allow for a faster submission of zorevunersen, a drug aimed at treating Dravet syndrome.

Following a meeting in December 2023, the FDA did not completely reject Stoke’s proposal to submit zorevunersen for approval later this year. This would allow the company to bypass the completion of an ongoing Phase 3 study, which is expected to conclude in mid-2027. In an interview, Stoke’s CEO Ian Smith mentioned that the FDA has requested additional information before moving forward.

Stoke Therapeutics is currently preparing to provide the necessary data to the FDA and anticipates making a decision on the regulatory pathway for zorevunersen by mid-2024. The company remains optimistic about its treatment, which targets a severe form of epilepsy that affects children.

The outcome of these discussions holds significant implications for patients suffering from Dravet syndrome, a condition characterized by frequent and severe seizures. As the timeline for regulatory approval remains uncertain, Stoke’s leadership is focused on navigating the complexities of the FDA process to bring this potential treatment to market as soon as possible.

Ongoing communication with the FDA will be crucial as Stoke Therapeutics aims to clarify the requirements needed for an expedited submission. The company expresses its commitment to addressing the needs of patients and families impacted by Dravet syndrome, highlighting the urgency of bringing effective therapies to those who need them most.