A New Drug Application (NDA) has been submitted to the Food and Drug Administration (FDA) for Dasiglucagon HypoPal® Rescue Pen (Zealand Pharma) for the treatment of severe hypoglycemia.
Dasiglucagon is a glucagon analog that is formulated in a ready-to-use aqueous solution for subcutaneous administration. The submission is supported by three phase 3 trials (NCT03688711, NCT03667053, NCT03378635) in adult and pediatric patients that demonstrated dasiglucagon met the primary and all key secondary end points with a median time to blood glucose recovery of 10 minutes following injection of 0.6mg dasiglucagon.
Among the 3 trials, the efficacy and safety of dasiglucagon was assessed in a pivotal phase 3 trial (NCT03378635) in 168 adults with type 1 diabetes. Patients were randomized 2:1:1 to receive dasiglucagon 0.6mg (n=82), placebo (n=43), or GlucaGen® (n=43).
Results showed that dasiglucagon achieved a median time to blood glucose recovery of 10 minutes vs 40 minutes with placebo, and 12 minutes with GlucaGen (P <.001). Moreover, 99% of patients treated with dasiglucagon recovered from insulin-induced hypoglycemia within 15 minutes vs 2% with placebo and 95% with GlucaGen.
Regarding safety, the most common treatment-emergent adverse events were nausea and vomiting, which were reported to be similar for dasiglucagon and GlucaGen (55% vs 53%; 23% vs 19%, respectively).
The Company is also investigating dasiglucagon for 3 additional indications: treatment of type 1 diabetes with a next-generation artificial pancreas, treatment for congenital hyperinsulinism (CHI), and the treatment and prevention of hypoglycemia in patients who have undergone gastric bypass bariatric surgery.
For more information visit zealandpharma.com.