FDA Grants Breakthrough Therapy Designation to Daridorexant for Pediatric Insomnia Disorder

Idorsia Ltd has announced that the U.S. Food and Drug Administration (FDA) granted Breakthrough Therapy Designation to daridorexant for treating insomnia disorder in patients aged 10 to less than 18 years. This designation acknowledges the clinical evidence supporting daridorexant and the significant unmet medical need in pediatric insomnia, where no FDA-approved pharmacological treatments are currently available.