UK MHRA approval for Byfavo for procedural sedation – Paion AG

PAION AG announces that the UK Medicines & Healthcare products Regulatory Agency (MHRA) has approved Byfavo (remimazolam besylate) in adults for procedural sedation. Byfavo is an ultra-short-acting intravenous benzodiazepine sedative/anesthetic. The decision follows the approval of the European Commission in the EU (including European Economic Area (EEA) countries) in March 2021.

The MHRA approval for Byfavo is based on data from a comprehensive U.S. Phase III clinical program in procedural sedation in patients undergoing bronchoscopy or colonoscopy. The safety and efficacy of Byfavo was evaluated in three pivotal studies in 984 patients undergoing colonoscopy (two studies) or bronchoscopy (one study), of whom 639 received Byfavo .

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).