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.
This article originally appeared on MPR