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FDA Grants Praxis ODD for PRAX-562 for the Treatment of SCN2A-DEE
On Wednesday, April 28, Praxis was granted orphan-drug designation (ODD) by the FDA for PRAX-562 for “treatment of SCN2A developmental and epileptic encephalopathy.” As was mentioned in the March SCN2A virtual community discussions, receiving an ODD is an important milestone in rare disease drug development because it is an acknowledgement that the sponsor (in this case, Praxis) has satisfied the FDA’s criteria for this designation. Receiving the ODD means that the FDA’s Office of Orphan Product Development recognizes that SCN2A is a rare pediatric disease, and that the scientific data emerging to date show promise for the continued advancement of PRAX-562 in SCN2A.
We are encouraged by this news and continue our commitment to make progress with PRAX-562.
To learn more, please review the Praxis press release on this news.