FDA approves Byfavo for procedural sedation in adults.- Acacia Pharma

Acacia Pharma announced that the FDA has approved Byfavo (remimazolam) for injection for the induction and maintenance of procedural sedation in adults undergoing procedures lasting 30 minutes or less. Acacia Pharma in-licensed the commercial rights to Byfavo for the US from Cosmo Pharmaceuticals NV in January 2020.

The safety and efficacy of Byfavo compared to a saline placebo with midazolam rescue treatment group and an open-label midazolam treatment group was evaluated in three randomized, double-blind, multicenter Phase III studies conducted in 969 adult patients undergoing colonoscopy (two studies) or bronchoscopy (one study), of whom 630 received Byfavo. In these studies, the most common adverse reactions (incidence greater than 10%) following Byfavo administration were hypotension, hypertension, diastolic hypertension, systolic hypertension, hypoxia, and diastolic hypotension.