The schedule shift stems from the company providing additional sensitivity analyses of existing clinical trial results. The FDA categorized this submission as a major amendment to the original application, necessitating the extra time for evaluation. Praxis officials confirmed that the agency has not requested new clinical studies, nor have any safety or manufacturing issues surfaced during the ongoing review process.
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FDA Pushes Back Deadline for Praxis Epilepsy Drug Review
The Food and Drug Administration has delayed its decision on relutrigine, an experimental treatment for rare childhood epilepsy, by three months. The regulatory body extended its target date to December 27, 2026, following the submission of supplementary data from the drug developer, Praxis Precision Medicines.
Relutrigine targets seizures triggered by specific SCN2A and SCN8A gene mutations. Praxis continues to coordinate with regulators to facilitate the remaining stages of the application review.
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