STAT+: FDA puts off Stoke’s request for faster filing of severe epilepsy drug

SAN FRANCISCO — Stoke Therapeutics and the Food and Drug Administration were unable to reach agreement on an expedited submission for the company’s severe epilepsy treatment, the company said Sunday. 

Following a meeting in December, the FDA did not shut the door on Stoke’s request to submit zorevunersen, a treatment for Dravet syndrome, later this year, rather than wait for the completion of an ongoing Phase 3 study in the middle of 2027, Stoke CEO Ian Smith told STAT in an interview. 

Instead, regulators asked the company to submit more information, and further discussions are planned. Stoke expects to make a decision on a regulatory path for zorevunersen by the middle of the year. 

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