Stoke Therapeutics has announced that its request for an expedited review of zorevunersen, a drug targeting severe epilepsy, has not received approval from the Food and Drug Administration (FDA). The company disclosed this development on Sunday, following a meeting held in December 2023.
During the meeting, the FDA did not completely dismiss Stoke’s request to file for zorevunersen ahead of the completion of an ongoing Phase 3 clinical trial, which is projected to conclude in mid-2027. According to Stoke’s CEO, Ian Smith, the FDA has instead requested additional information from the company. Discussions regarding the regulatory pathway for zorevunersen will continue in the coming months.
Future Steps for Zorevunersen
Stoke is currently focused on determining the best course of action for zorevunersen within the next few months. The drug aims to provide a new treatment option for patients suffering from Dravet syndrome, a severe form of epilepsy that often begins in infancy.
The Phase 3 trial is crucial for the drug’s approval, but Stoke is exploring the possibility of submitting data that may allow for an earlier review. The company will communicate its decision on the regulatory path for zorevunersen by mid-2024.
This delay in the approval process highlights the complexities involved in bringing new treatments to market, especially for conditions like Dravet syndrome, which affect vulnerable populations. Stoke remains committed to working with the FDA to facilitate the review process and improve treatment options for those in need.
As the situation develops, stakeholders in the epilepsy treatment community are keenly observing Stoke’s next steps and the FDA’s response.
