Stoke Therapeutics announced that the Food and Drug Administration (FDA) has not approved its request for an expedited submission of zorevunersen, a treatment for severe epilepsy. The company made this statement on Sunday, following discussions with the FDA earlier in December 2023.
During their meeting, the FDA did not entirely dismiss Stoke’s proposal to submit zorevunersen for approval later this year. The alternative plan would allow the company to bypass waiting for the completion of an ongoing Phase 3 clinical trial, which is projected to conclude in mid-2027. According to Stoke’s CEO, Ian Smith, the regulatory body requested additional information regarding the drug before moving forward.
Stoke Therapeutics remains optimistic about the path ahead. The company expects to finalize its strategy regarding the regulatory submission for zorevunersen by mid-2024. Further discussions with the FDA are anticipated, which could clarify the requirements for a potential expedited filing.
The treatment zorevunersen is specifically designed for Dravet syndrome, a severe form of epilepsy that often leads to significant developmental challenges. The ongoing Phase 3 study aims to assess the drug’s safety and efficacy, providing critical data for regulatory approval.
Stoke’s plans reflect its commitment to addressing the urgent needs of patients suffering from this debilitating condition. The company is dedicated to advancing its research while navigating the complexities of regulatory processes. As Stoke prepares for the next steps, the focus remains on ensuring that zorevunersen can reach those in need as efficiently as possible.
