Stoke Therapeutics announced that it has not reached an agreement with the Food and Drug Administration (FDA) regarding an expedited submission for its treatment targeting severe epilepsy. During a meeting in December 2023, the FDA did not completely dismiss Stoke’s appeal to submit data for zorevunersen, a drug designed for individuals with Dravet syndrome, before the completion of its ongoing Phase 3 study, which is expected to conclude in the middle of 2027.
In an interview with STAT, Stoke CEO Ian Smith explained that while the FDA has requested additional information, further discussions are anticipated. He emphasized that the company remains hopeful about the potential for an earlier submission. The FDA’s feedback suggests that there is still a pathway for Stoke to present its findings sooner than originally planned.
Stoke is now focusing on compiling the necessary data and expects to make a definitive decision on the regulatory strategy for zorevunersen by mid-2024. This timeline is critical as the company looks to address the needs of patients suffering from this severe form of epilepsy, which can have devastating effects on quality of life.
The ongoing dialogue between Stoke and the FDA illustrates the complexities involved in bringing new treatments to market, particularly for serious conditions like Dravet syndrome. As patients and families await further developments, the urgency of effective treatment options remains at the forefront of discussions within the medical community.
With the potential to significantly impact the lives of those affected by this debilitating condition, Stoke’s efforts to expedite its submission reflect both the challenges and hopes that accompany groundbreaking therapies in the pharmaceutical landscape.
