The pen is an emergency treatment for diabetes patients above the age of six in the case of a sudden and severely low blood glucose level known as hypoglycemia, writes Zealand Pharma on Monday evening.
"This approval will help enable appropriate children and adults with diabetes to be able to address sudden and severe hypoglycemia, which can quickly progress from a mild event to an emergency," said Dr. Jeremy Pettus, MD, Assistant Professor of Medicine at the University of California San Diego in the firm's press announcement.
The approval from the US Food and Drug Administration (FDA) is valid for diabetes patients at the age of 6 and above.
This authorization is based around results from three phase III trials involving adults and children with diabetes showing median time to blood glucose recovery from severe hypoglycemia of 10 minutes following injection of 0.6 mg/0.6 mL Zegalogue, according to Zealand Pharma.
The statement notes that Zegalogue will be launched on the US market in June, according to the press release.
Zealand Parma has also tried developing dasiglucagon for treating hyperinsulinism. This is a hereditary disease causing low blood sugar due to an excess of insulin in the body.
In December, the firm announced that sasiglucacon for hyperinsulinism did not meet its primary endpoint in the phase III trial.
However, some of the partial aims of the trial showed encouraging results, so Zealand Pharma is keeping up its developmental efforts.
Alongside its partner Beta Bionics, Zealand Pharma is also developing an artificial pancreas pump which will help diabetes patients regulate insulin and glucagon.
In healthy individuals the pancreas produces the hormones insulin and glucagon. This insulin is released to lower the blood sugar, while glucagon can raise it, if it goes too low.
Hormones are an essential tool in regulating patients' blood sugar levels. Zealand Pharma has entered into collaborations with Beta Bionics, and it hopes to develop a pancreas system involving both hormones.
Previously, Glucagon has only been presented in solid form. This meant it had to be resolved, which meant it did not last very long, since it was fairly unstable and tended to clot.
Zealand Pharma's sasiglucagon, however, has proven to be more stable and has kept its liquid form for longer in room temperature.
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