Praxis Precision Medicines receives PRIME designation from EMA for PRAX-222

Praxis Precision Medicines announced that the European Medical Agency, EMA, has awarded its Priority Medicines, PRIME, designation for elsunersen, PRAX-222, for the treatment of SCN2A Gain of Function developmental and epileptic encephalopathy. The EMA’s PRIME designation provides enhanced development support for priority medicines that target an unmet need and was granted based on the Part 1 data from the EMBRAVE study that showed a reduction in seizures and improvement in seizure free days, as well as preclinical data. “Elsunersen has the potential to significantly impact the lives of patients with SCN2A-DEE and their families,” said Marcio Souza, president and chief executive officer of Praxis. “We welcome the recognition by the EMA of not only the unmet need in the condition, but the breakthrough potential of elsunersen and look forward to working closely with patients and regulators globally to advance the program.”