FDA Grants Daridorexant Breakthrough Designation for Pediatric Insomnia
Story updates
06:02:03 AM UTC
SquawkNews
The FDA recognizes through this designation both the clinical evidence supporting daridorexant and the significant unmet medical need in pediatric insomnia, where no FDA-approved pharmacological treatments are currently available.The positive large Phase 2 study demonstrated a statistically signifi…
06:02:07 AM UTC
SquawkNews
The FDA granted daridorexant Breakthrough Therapy Designation for insomnia in patients aged 10 to under 18. Idorsia expects to initiate a Phase 3 program in the second half of next year.Material DetailsContext by AI AnalystThis is a mid-cycle clinical development update, adding FDA support to posit…