Stoke Therapeutics announced that it did not reach an agreement with the Food and Drug Administration (FDA) regarding an expedited submission for its severe epilepsy treatment, zorevunersen. The company’s chief executive, Ian Smith, shared this update during an interview following a meeting held in December 2023. The FDA has not completely dismissed the possibility of Stoke submitting its application for zorevunersen, which targets Dravet syndrome, before the completion of the ongoing Phase 3 study projected for mid-2027.
In a recent statement, Stoke indicated that the FDA has requested additional information before moving forward with the submission process. While the company had hoped for a quicker pathway, this request means that further discussions will be necessary. The FDA’s approach suggests that regulators are open to continued dialogue about the treatment’s potential, though it requires a comprehensive evaluation of the data before any decision is made.
Stoke Therapeutics is now focused on assessing its regulatory strategy for zorevunersen. The company expects to announce its decision by the middle of 2024, as it navigates the complexities of regulatory requirements and strives to expedite access for patients suffering from severe epilepsy, specifically those affected by Dravet syndrome. This syndrome is a rare and severe form of epilepsy that can lead to significant developmental delays and is characterized by frequent and prolonged seizures.
The ongoing Phase 3 study is crucial for determining the efficacy and safety of zorevunersen. Completion of this study will provide vital data that the FDA requires for a comprehensive review. Despite the setback, Stoke remains optimistic about the potential of its treatment and the importance of bringing new options to market for patients in need.
As Stoke Therapeutics continues its discussions with the FDA, the company emphasizes its commitment to advancing zorevunersen and its dedication to serving the epilepsy community. With a decision expected in the coming months, all eyes will be on how the regulatory landscape unfolds for this promising treatment.
