17July 2025 - The breakthrough therapy designation was granted based on the highly compelling results from the Phase 2 EMBOLD trial in SCN2A and SCN8A developmental and epileptic encephalopathies.
Praxis Precision Medicines today announced that the US FDA has granted breakthrough therapy designation for relutrigine, a sodium channel functional state modulator for paediatric use for the treatment of patients with SCN2A and SCN8A developmental and epileptic encephalopathies.