The Food and Drug Administration (FDA) has postponed a decision regarding Stoke Therapeutics’ request for an expedited filing of its severe epilepsy treatment, zorevunersen. The announcement came on Sunday after a meeting held in December 2023, where the agency did not entirely dismiss the possibility of a faster submission for the drug, which targets Dravet syndrome.
Stoke’s CEO, Ian Smith, shared insights from the discussions with the FDA, stating that the agency has requested additional information before making a final decision. Instead of waiting for the results of an ongoing Phase 3 study expected to conclude by mid-2027, the FDA has indicated it is open to further dialogue regarding the regulatory pathway for zorevunersen.
Stoke plans to determine its approach to regulatory submissions for zorevunersen by mid-2024. The company is optimistic about engaging with the FDA in the coming months to provide the necessary information that could facilitate an expedited review process.
The FDA’s cautious stance reflects its commitment to ensuring the safety and efficacy of new treatments while balancing the urgent need for effective therapies for severe epilepsy conditions like Dravet syndrome. As the situation develops, Stoke Therapeutics will continue to work closely with regulatory officials to navigate the complexities of drug approval processes.
This pivotal moment for Stoke Therapeutics highlights the challenges faced by pharmaceutical companies in bringing innovative treatments to market, particularly for conditions that currently have limited treatment options. The outcome of this regulatory dialogue could significantly impact patients and families affected by Dravet syndrome, underscoring the importance of timely access to effective therapies.
