BRIEF—UK approval for Byfavo

German specialty pharma company Paion has picked up UK approval for Byfavo (remimazolam besylate) as an option for procedural sedation.

Byfavo is an ultra-short-acting intravenous benzodiazepine sedative/anesthetic, and the company is planning to launch in the UK in the second half of 2021.

The approval from the Medicines and Healthcare Products Regulatory Agency (MHRA) is based on data from a USA-based Phase III program which demonstrated safety and efficacy in 984 patients undergoing colonoscopy or bronchoscopy.

The firm also plans to submit to the European regulator to broaden the label, to include use as a general anesthesia, by the end of 2021. Intensive care unit sedation is another possible indication for the product.

Byfavo is approved in the USA, the EU, UK and China for procedural sedation and in Japan and South Korea for general anesthesia.