FDA Sets March 2027 PDUFA Date for Aquestive's Anaphylm Resubmission
Event summary
- FDA accepted Aquestive's resubmission of Anaphylm NDA as complete, setting a PDUFA goal date of March 16, 2027.
- Anaphylm is a sublingual film for treating Type I allergic reactions, including anaphylaxis.
- Aquestive plans to submit a New Drug Submission to Health Canada in Q4 2026.
- Anaphylm, if approved, would be the first oral rescue medication for severe allergic reactions.
The big picture
Aquestive's Anaphylm represents a novel approach to treating anaphylaxis, leveraging sublingual film technology. The FDA's acceptance of the resubmission is a critical milestone, but the company must now navigate the regulatory review process while preparing for a potential launch. Success could position Aquestive as a key player in the allergy treatment market, though competition and reimbursement dynamics remain key variables.
What we're watching
- Regulatory Approval
- Whether the FDA will approve Anaphylm by the March 2027 PDUFA date, given the Class 2 response classification.
- Market Differentiation
- How Anaphylm's unique delivery mechanism will position it against existing epinephrine treatments if approved.
- Commercial Readiness
- The pace at which Aquestive can scale commercial preparations for Anaphylm's potential launch.