CHMP Recommends EU Marketing Authorization for Baqsimi

The Committee for Medicinal Products for Human Use (CHMP) of the European Medicines Agency (EMA) has recommended that Baqsimi (glucagon), a non-injectable treatment for severe hypoglycemia, be granted marketing authorization in the European Union (EU).

Currently, the only available treatment for patients with severe hypoglycemia, outside of a hospital or emergency medical setting, is injectable glucagon. Baqsimi is a novel pharmaceutical formulation that can be administered nasally using a single-use dispenser.

Efficacy and safety of this new pharmaceutical formulation of glucagon have been evaluated in two studies involving more than 150 patients in total with diabetes and insulin-induced hypoglycemia. In the studies, it was found that Baqsimi was effective at increasing blood sugar levels in a 30-minute time period (after administration) to a similar level of the injected glucagon. Safety of Baqsimi was also found to be equivalent to that of injected glucagon. Additionally, similar results were found in a pediatric study of 48 patients aged four years and older.

As part of the recommendation, CHMP advised additional risk minimization measures so that any potential risk of misuse of the device are lessened and prevented. The recommended measures included a demonstration kit with a training device, an administration leaflet, and an instructional video.

The opinion of the CHMP will be put forward to the European Commission for consideration on EU-wide marketing authorization. The applicant for marketing authorization of Baqsimi is Eli Lilly Nederland.

Source: EMA