regulatory
confidence high
sentiment positive
materiality 0.75
FDA approves Libervant for seizure clusters in children 2-5; Anaphylm NDA on track for end of 2024
Aquestive Therapeutics, Inc.
- Libervant is first FDA-approved oral rescue treatment for seizure clusters in patients ages 2-5.
- Immediate availability of 5mg, 7.5mg, 10mg, 12.5mg, and 15mg; non-Medicaid prescriptions being filled.
- Over 55,000 prescriptions filled in 2023 for this age group, 90% for diazepam rectal gel.
- Anaphylm clinical program on track; NDA submission planned by end of 2024.
- This is the Company's 4th FDA approval since 2018.