Stoke Therapeutics has announced that the Food and Drug Administration (FDA) has not approved its request for an expedited filing regarding the company’s treatment for severe epilepsy. This decision follows a meeting held in December, during which Stoke sought permission to submit zorevunersen, a drug aimed at treating Dravet syndrome, earlier than the anticipated timeline.
In a recent interview, Stoke CEO Ian Smith revealed that while the FDA did not grant the expedited submission, it has not completely dismissed the possibility. The regulatory body has requested additional information from the company, indicating that further discussions are planned. This suggests that there may still be a pathway for Stoke to present its case for zorevunersen before the completion of an ongoing Phase 3 study, which is expected to conclude in mid-2027.
Despite this setback, Stoke is optimistic about its future with zorevunersen. The company plans to make a decision regarding its regulatory strategy by mid-2024. The ongoing dialogue with the FDA is crucial for Stoke as it navigates the complexities of bringing its treatment to market.
The company has been under pressure to expedite the process due to the urgent need for effective treatments for Dravet syndrome, a severe form of epilepsy that can lead to significant developmental challenges. As Stoke works to meet regulatory expectations, families affected by the condition are watching closely for updates on the drug’s progress.
With zorevunersen positioned as a potential breakthrough therapy, stakeholders are hopeful that the ongoing collaboration between Stoke and the FDA will yield positive results. The next steps in this regulatory journey will be pivotal for both the company and patients awaiting new treatment options.
