Aquestive Therapeutics provides international expansion update for Anaphylm

Aquestive Therapeutics (AQST) announced that Health Canada has granted the Company a meeting to discuss Aquestive’s planned New Drug Submission for Anaphylm Sublingual Film in Canada. In addition, the Company has submitted an initial briefing book to the European Medicines Agency. The Company plans to submit a Marketing Authorization Application to the EMA as soon as possible. The Company’s ex-U.S. regulatory strategy prioritizes markets with significant unmet medical needs and regulatory frameworks conducive to innovative therapies. EMA and Canada represent ideal initial international markets given their collaborative regulatory environment and substantial population of patients requiring reliable anaphylaxis treatment options. Aquestive will continue to provide updates on its global regulatory approval progress as it works to establish Anaphylm as the new standard of care for the treatment of severe allergic reactions and anaphylaxis worldwide.