Praxis Says FDA Grants Rare Pediatric Disease Designation to Relutrigine to Treat Dravet Syndrome

MT Newswires Live12-18

Praxis Precision Medicines (PRAX) said Wednesday that the Food and Drug Administration has granted Rare Pediatric Disease Designation to relutrigine to treat Dravet Syndrome.

Rare pediatric diseases are defined by the FDA as serious or life-threatening conditions primarily affecting children under 18, with fewer than 200,000 cases in the US. A key benefit of the drug designation is the potential to receive a priority review voucher following FDA approval, under certain conditions, the company said.

Dravet syndrome is a severe, progressive genetic epilepsy that typically begins within the first year of life, and causes frequent, prolonged and treatment-resistant seizures.

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