The Committee for Medicinal Products for Human Use (CHMP) of the European Medicines Agency (EMA) has recommended granting marketing authorisation in the European Union (EU) for Baqsimi, the first nasally administered glucagon therapy for severe hypoglycaemia in patients aged four years and older.
The efficacy and safety of Baqsimi has been evaluated in two studies of 83 and 70 adults with diabetes and insulin-induced hypoglycaemia. Baqsimi adequately increased serum glucose levels within 30 minutes of administration and was shown to be as efficient and safe as injected glucagon. In a paediatric study of 48 patients over the age of four years with type 1 diabetes, similar results were observed.
Side effects of Baqsimi are similar to injectable glucagon, with the addition of nasal and eye-related symptoms.
The CHMP recommended risk minimisation measures to reduce and prevent inappropriate use of the device. These include a demonstration kit with a training device, an administration leaflet and an instructional video.
The opinion adopted by the CHMP will now be sent to the European Commission for the adoption of a decision on EU-wide marketing authorisation. Decisions on price and reimbursement will take place at the level of each Member State.