Aquestive Therapeutics receives confirmation from the FDA that no advisory committee meeting is needed for Anaphylm™.
The NDA for Anaphylm remains on track for the FDA PDUFA goal date of January 31, 2026.
Commercial planning is underway for a rapid launch post-approval.
FDA Confirmation
FDA informs Aquestive that no advisory committee meeting is required for Anaphylm™ approval.
PDUFA Goal Date
The Prescription Drug User Fee Act deadline for Anaphylm is set for January 31, 2026.
Innovative Epinephrine Solution
Anaphylm could become the first FDA-approved sublingual epinephrine film for anaphylaxis treatment.
- Anaphylm offers a device-free, needle-free epinephrine option for severe allergic reactions, addressing needle aversion.
- The novel sublingual film provides a user-friendly alternative to traditional auto-injectors, potentially improving treatment adherence.
The FDA's decision not to require an advisory committee meeting is a positive step forward for Aquestive Therapeutics and Anaphylm™, setting the stage for a potential transformative advancement in anaphylaxis treatment.