Stoke Therapeutics announced that it has not reached an agreement with the Food and Drug Administration (FDA) for an expedited submission of its treatment for severe epilepsy. The company’s CEO, Ian Smith, shared this update following a meeting with FDA officials on December 2023.
The FDA has not completely ruled out the possibility of Stoke submitting zorevunersen, a drug aimed at treating Dravet syndrome, before the ongoing Phase 3 study concludes in the middle of 2027. Instead, the agency requested additional information from Stoke to support its submission. Further discussions between the two parties are expected in the coming months.
Stoke is now focusing on determining a regulatory strategy for zorevunersen, with a decision anticipated by the middle of the year. The company remains optimistic about the potential for an earlier filing, which could significantly impact patients with Dravet syndrome, a severe form of epilepsy that often does not respond well to traditional treatments.
The outcome of these discussions will be crucial, as zorevunersen represents a promising therapeutic option for individuals suffering from this challenging condition. The FDA’s willingness to engage in further dialogue suggests that there may still be a pathway for expedited approval, depending on the forthcoming data and information provided by Stoke.
As the situation develops, stakeholders will be watching closely for updates on the regulatory journey of zorevunersen and its implications for the epilepsy treatment landscape.
