dm+d

Unassigned

New Medicines

Zegalogue (US) Hypoglycaemia

Information

Zegalogue (US)
New molecular entity
Zealand
Zealand

Development and Regulatory status

Phase III Clinical Trials
Phase III Clinical Trials
Approved (Licensed)
May 20US FDA accepts NDA with a PDUFA date of 27/3/21 [7].
Sep 19Zealand plan to submit a NDA to US FDA H1 2020 [6].
Approved in US for treatment of severe hypoglycaemia in people with diabetes [7].

Category

Stable analogue of glucagon in ready to use pen
Frequency unclear; diabetes treated with insulin or sulfonylureas is common cause [2].
Hypoglycaemia
Subcutaneous injection

Trial or other data

Apr 21PIII RCT (n=170) found dasiglucagon provided rapid and effective reversal of hypoglycaemia in adults with type 1 diabetes, with similar safety and tolerability to reconstituted glucagon injection [7].
Sep 19Primary and secondary endpoints of PIII NCT03667053 met (n=42). Median time to blood glucose recovery was 10 minutes for dasiglucagon vs 30 minutes for placebo (p<0.001). Overall, no safety concerns were raised [6].
May 19Primary and secondary endpoints of PIII NCT03688711 met (n=45). Median time to blood glucose recovery was 10 minutes for dasiglucagon vs 35 minutes for placebo (p<0.001). Overall, no safety concerns were raised for dasiglucagon within the trial [5].
Sep 18Zealand begin recruiting to a PIII paediatric study NCT03667053. Estimated primary completion date of study is 1/7/19. Filings are expected Q2 2019 [3,4].
Mar 18Primary and key secondary objectives of PIII trial of dasiglucagon for treatment of severe hypoglycemia were met. No treatment-induced or treatment-boosted anti-drug antibodies were detected in the trial [1].

Hypoglycaemia associated with congenital hyperinsulinism (CHI)

Information

Licence extension / variation
Zealand
Zealand

Development and Regulatory status

Phase III Clinical Trials
Phase III Clinical Trials
Phase III Clinical Trials
Yes
Yes

Category

Stable analogue of glucagon
Prevalence of congenital hyperinsulinism is estimated at 1/50,000 live births [2].
Hypoglycaemia associated with congenital hyperinsulinism (CHI)
Subcutaneous infusion