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▎The content team editor of WuXi AppTec recently announced that the US FDA has approved the company’s soluble glucagon analogue Zegalogue (dasiglucagon) for the treatment of severe hypoglycemia in children over 6 years old and adults with diabetes.
.
In clinical trials, this fast-acting innovative therapy can restore 99% of patients' blood glucose levels within 15 minutes after injection.
All type 1 diabetes patients and the most severe type 2 diabetes patients rely on receiving insulin injections to control their blood sugar levels.
This means that diabetic patients need to monitor and adjust their blood sugar levels at all times.
Excessive or low blood sugar levels will affect their health.
Severe hypoglycemia is an acute complication that may be brought about by insulin therapy and may be life-threatening.
For diabetic patients who need multiple insulin injections per day, the risk of severe hypoglycemia is significantly increased, which is the acute complication they are most worried about.
At present, glucagon, which restores blood sugar levels, is a powdery preparation due to its low stability.
It needs to be dissolved before being injected into the patient, which brings inconvenience to the rescue of patients with severe hypoglycemia.
Zegalogue is a glucagon analogue developed by the Zealand company.
It has a unique stability and can exist stably in the state of an aqueous solution.
Zealand also developed an auto-injector called HypoPal, which can be operated by diabetic patients to quickly treat severe hypoglycemia.
This approval is supported by three randomized, double-blind, placebo-controlled Phase 3 clinical trials.
In 3 clinical trials, the median time for patients to recover blood sugar after the injection was 10 minutes, which was significantly lower than the 30-45 minutes in the placebo group.
99% of patients' blood glucose levels recovered within 15 minutes.
▲Zegalogue quickly restored blood glucose levels in patients with hypoglycemia in three phase 3 clinical trials (picture source: the official website of the Zealand company) "Severe hypoglycemia can rapidly progress from mild symptoms to critical symptoms, so every minute of treatment is very good Important.
"Professor Jeremy Pettus of the University of California, San Diego said: "This approval provides an option for children and adults with diabetes to resolve sudden severe hypoglycemia.
"Reference: [1] Zealand Pharma Announces FDA Approval of Zegalogue®(dasiglucagon) injection, for the Treatment of Severe Hypoglycemia in Peoplewith Diabetes.
Retrieved March 24, 2021, from http:// /2021/03/22/2197267/0/en/Zealand-Pharma-Announces-FDA-Approval-of-Zegalogue-dasiglucagon-injection-for-the-Treatment-of-Severe-Hypoglycemia-in-People-with-Diabetes .
html[2] ZEGALOGUE® (dasiglucagon) injection for the treatment of severe hypoglycemia in patients with diabetes ages six years and above.
USFDA APPROVAL CONFERENCE CALL.
Retrieved March 24, 2021, from https://static1.
squarespace.
com/static/ 58983777d1758e28995640b4/t/6059dc40cce1a531066918b4/1616501826861/Zegalogue+approval+slide+deck_Investor+Presentation_FINAL+3.
22.
21.
pdf Note: This article aims to introduce medical and health research progress, not a treatment plan recommendation.
If you need treatment plan guidance, please go to a regular hospital See a doctor.
.
In clinical trials, this fast-acting innovative therapy can restore 99% of patients' blood glucose levels within 15 minutes after injection.
All type 1 diabetes patients and the most severe type 2 diabetes patients rely on receiving insulin injections to control their blood sugar levels.
This means that diabetic patients need to monitor and adjust their blood sugar levels at all times.
Excessive or low blood sugar levels will affect their health.
Severe hypoglycemia is an acute complication that may be brought about by insulin therapy and may be life-threatening.
For diabetic patients who need multiple insulin injections per day, the risk of severe hypoglycemia is significantly increased, which is the acute complication they are most worried about.
At present, glucagon, which restores blood sugar levels, is a powdery preparation due to its low stability.
It needs to be dissolved before being injected into the patient, which brings inconvenience to the rescue of patients with severe hypoglycemia.
Zegalogue is a glucagon analogue developed by the Zealand company.
It has a unique stability and can exist stably in the state of an aqueous solution.
Zealand also developed an auto-injector called HypoPal, which can be operated by diabetic patients to quickly treat severe hypoglycemia.
This approval is supported by three randomized, double-blind, placebo-controlled Phase 3 clinical trials.
In 3 clinical trials, the median time for patients to recover blood sugar after the injection was 10 minutes, which was significantly lower than the 30-45 minutes in the placebo group.
99% of patients' blood glucose levels recovered within 15 minutes.
▲Zegalogue quickly restored blood glucose levels in patients with hypoglycemia in three phase 3 clinical trials (picture source: the official website of the Zealand company) "Severe hypoglycemia can rapidly progress from mild symptoms to critical symptoms, so every minute of treatment is very good Important.
"Professor Jeremy Pettus of the University of California, San Diego said: "This approval provides an option for children and adults with diabetes to resolve sudden severe hypoglycemia.
"Reference: [1] Zealand Pharma Announces FDA Approval of Zegalogue®(dasiglucagon) injection, for the Treatment of Severe Hypoglycemia in Peoplewith Diabetes.
Retrieved March 24, 2021, from http:// /2021/03/22/2197267/0/en/Zealand-Pharma-Announces-FDA-Approval-of-Zegalogue-dasiglucagon-injection-for-the-Treatment-of-Severe-Hypoglycemia-in-People-with-Diabetes .
html[2] ZEGALOGUE® (dasiglucagon) injection for the treatment of severe hypoglycemia in patients with diabetes ages six years and above.
USFDA APPROVAL CONFERENCE CALL.
Retrieved March 24, 2021, from https://static1.
squarespace.
com/static/ 58983777d1758e28995640b4/t/6059dc40cce1a531066918b4/1616501826861/Zegalogue+approval+slide+deck_Investor+Presentation_FINAL+3.
22.
21.
pdf Note: This article aims to introduce medical and health research progress, not a treatment plan recommendation.
If you need treatment plan guidance, please go to a regular hospital See a doctor.