fbpx
Sign Up

UK MHRA approval for Byfavo for procedural sedation – Paion AG

Written by | 17 Jul 2021 | Anaesthesia

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).

Newsletter Icon

Register for our mailing list

If you're a healthcare professional you can sign up to our mailing list to receive high quality medical, pharmaceutical and healthcare E-Mails and E-Journals. Get the latest news and information across a broad range of specialities delivered straight to your inbox.

Sign Up

You can unsubscribe at any time using the 'Unsubscribe' link at the bottom of all our E-Mails, E-Journals and publications.