Praxis Precision Medicines, Inc. 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 (GoF) developmental and epileptic encephalopathy (DEE). 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. The PRIME designation provides early and proactive support to developers of promising medicines that may offer a major therapeutic advantage over existing treatments or a benefit to patients without treatment options.

These medicines are considered priority medicines by the EMA, whose aim is to optimize development plans and accelerate evaluations so medicines that address significant unmet medical needs can reach patients faster.