Stoke Therapeutics faced a setback as the Food and Drug Administration (FDA) declined the company’s request for an expedited submission of its epilepsy treatment, zorevunersen, designed for patients with Dravet syndrome. This update was shared by Stoke CEO Ian Smith in an interview, following a meeting between the two parties.
During discussions held in December, the FDA did not completely dismiss the possibility of Stoke submitting the treatment for review later this year. Instead, the agency requested additional information from the company. This means that Stoke must continue its dialogue with regulators as it seeks to advance the approval process for zorevunersen.
The ongoing Phase 3 clinical study for zorevunersen is not expected to conclude until mid-2027. Despite this timeline, Stoke aims to decide on a possible regulatory path for the drug by the middle of this year. The company remains committed to seeking a quicker route for bringing this potential treatment to patients suffering from severe epilepsy.
In light of this development, Stoke has indicated its readiness to respond to the FDA’s information requests. The company believes that providing the necessary data could strengthen its position for an earlier filing. The situation highlights the complex nature of drug approval processes, particularly for therapies targeting rare and serious conditions like Dravet syndrome.
As the dialogue between Stoke Therapeutics and the FDA progresses, stakeholders in the healthcare sector will be closely monitoring any updates. The potential for zorevunersen to become available sooner could significantly impact the lives of those affected by this challenging form of epilepsy. Further discussions between Stoke and the FDA are expected in the coming months as the company works to navigate the regulatory landscape effectively.
