7 January 2021 - FDA grants RPD and ODD for PRAX-222 for treatment of SCN2A-DEE.
Praxis Precision Medicines today announced that the U.S. FDA has granted both rare paediatric disease and orphan drug designations for PRAX-222 for the treatment of SCN2A developmental and epileptic encephalopathy (SCN2A-DEE).
The FDA has also granted rare paediatric disease designation for PRAX-562 for the treatment of SCN2A-DEE and for the treatment of SCN8A developmental and epileptic encephalopathy (SCN8A-DEE).