Stoke Therapeutics announced that it has not reached an agreement with the Food and Drug Administration (FDA) regarding a faster filing for its drug aimed at treating severe epilepsy. In a statement on Sunday, the company revealed the regulatory body did not dismiss the possibility of an expedited submission for zorevunersen, a treatment specifically designed for Dravet syndrome.
Following a meeting in December 2023, FDA representatives requested additional information from Stoke rather than outright rejecting the company’s proposal. This decision indicates that while the agency is not ready to approve an expedited process, it is open to further discussions. Ian Smith, CEO of Stoke Therapeutics, explained in an interview that the company is anticipating a decision on the regulatory path for zorevunersen by mid-year.
The current timeline indicates that Stoke would have to wait for the completion of an ongoing Phase 3 study, which is expected to conclude in mid-2027, before it can submit its drug for formal approval. This delay raises questions about the potential impact on patients suffering from severe forms of epilepsy, particularly those affected by Dravet syndrome, who may need quicker access to new treatments.
Stoke is actively working to provide the FDA with the necessary information to support its case for an expedited review, which it hopes will lead to a more favorable outcome. The company remains committed to advancing its clinical program and addressing the needs of patients who currently have limited treatment options.
As discussions with the FDA continue, stakeholders in the epilepsy community will be closely monitoring the situation. The regulatory landscape surrounding new drug approvals is crucial for the development of innovative therapies, especially for conditions that severely impact quality of life.
Stoke’s efforts reflect a broader trend in the pharmaceutical industry, as companies seek to navigate complex regulatory frameworks while striving to bring new treatments to market as quickly as possible. The outcome of this situation will ultimately have significant implications for both the company and the patients awaiting new therapeutic options.