US FDA declines approval of Aquestive's oral allergy drug

The U.S. Food and Drug Administration issued a complete response letter declining approval of Aquestive's oral treatment Anaphylm over packaging and labeling concerns rather than efficacy; the company says it has revised packaging and instructions and expects to resubmit as early as the third quarter of 2026.

A U.S. regulator has declined to approve an oral treatment for severe allergic reactions developed by Aquestive Therapeutics. The article reports the FDA issued a complete response letter dated January 30 that raised concerns about packaging and how the product is used, not about the drug's efficacy. Aquestive has updated the pouch opening, instructions, and labels and plans another user study. The FDA also asked for one additional blood‑level study to check whether the changes affect how the drug is taken up by the body. What happened: - The FDA issued a complete response letter on January 30 declining approval of Anaphylm, citing packaging and use concerns rather than efficacy. - Aquestive has revised the pouch opening, updated instructions, and changed pouch and carton labels, and plans to run another user study. - The FDA requested an additional blood‑level (pharmacokinetic) study to assess the impact of the packaging and labeling changes. - The article mentions Aquestive expects to resubmit as early as the third quarter of 2026 and plans regulatory filings in Europe and Canada in the second half of 2026, with feedback from the UK regulator expected in the first quarter. Summary: The FDA's decision pauses U.S. approval of Aquestive's oral anaphylaxis treatment while regulators review packaging and labeling changes. Aquestive plans further user testing and an additional blood‑level study, and expects to resubmit as early as Q3 2026. The company also intends to pursue filings in Europe and Canada later in 2026.