for severe allergic reactions (anaphylaxis) — emergency treatment
NDA· Priority Review
FDA issued a Complete Response Letter for the Anaphylm NDA on February 2, 2026. Specific deficiency details would require sponsor 8-K review; sublingual epinephrine bioavailability and consistency in stressed-anaphylaxis conditions are the typical regulatory concerns.
About
Anaphylaxis is a severe allergic reaction where the immune system overreacts to harmless substances, causing life-threatening symptoms like swelling and breathing difficulties. Anaphylm is a sublingual film that delivers epinephrine, a hormone that rapidly reverses the effects of anaphylaxis by relaxing airway muscles and tightening blood vessels. By providing a quick and easy-to-administer dose of epinephrine, Anaphylm could help stabilize patients during an emergency allergic reaction.
