PAION AG receives European Commission approval for Byfavo for procedural sedation.

PAION AG announces that the European Commission (EC) has approved Byfavo(R) (remimazolam) in adults for procedural sedation. Byfavo(R) is an ultra-short-acting intravenous benzodiazepine sedative/anesthetic. Remimazolam is also in development for general anesthesia. Based on the positive results in the European Phase III trial in this indication, PAION plans to submit an extension variation to the Marketing Authorization for remimazolam for general anesthesia by the end of 2021. The approval process for an extension variation is generally faster than for a Marketing Authorization Application (MAA).