Sunday, May 15, 2022

Zealand Pharma’s hypoglycaemia therapy Zegalogue scores approval in the US

Zealand Pharma’s injectable therapy Zegalogue has been approved by the US Food and Drug Administration (FDA) for the treatment of severe hypoglycaemia in people with diabetes.

The FDA approval is supported by efficacy data from three phase III studies of Zegalogue (dasiglucagon) in children aged six to 17 and in adults with type 1 diabetes.

For all three studies, the primary efficacy endpoint was time to plasma glucose recovery, defined as an increase in blood glucose of ≥20 mg/dL from time of administration, without additional intervention within 45 minutes.

This was successfully achieved across both the paediatric and adult populations, with a ‘significantly’ faster median time to blood glucose recovery of ten minutes following Zegalogue administration compared to 30-45 minutes for placebo.

In addition, 99% of patients recovered within 15 minutes in the main phase III adult trial.

“The US FDA approval of Zegalogue is an exciting achievement for both patients and Zealand,” said Emmanuel Dulac, president and chief executive officer of Zealand Pharma.

“We would like to thank the trial participants, their families and caregivers, the investigators and their staff, and our employees who made the Zegalogue clinical studies and this resulting approval possible,” he added.

Source link

Latest Articles

Widely used chemical linked to 1,00,000 US deaths per year: Study

NEW YORK: Daily exposure to phthalates, a group of chemicals used in everything from plastic containers to makeup, may lead to approximately 100,000 deaths...

Foods to Reduce Inflammation and Strengthen the Immune System

Did you know that you can greatly reduce inflammation and boost your immune system by simply incorporating more anti-inflammatory foods and beverages into your...

Personal Selling

INTRODUCTION Early sellers and traders were not held in high esteem. The Roman word for salesman meant ‘Cheater’ and...

Building Muscle on a Vegan Diet

There are a lot of  misconceptions surrounding veganism. The notion that those who practice it are lacking in protein and therefore muscles is the...

Electrodes in brain new hope for severe cases of epilepsy

Neurosurgeons at All India Institute of Medical Sciences have devised a new technique for operating on children suffering from a severe form of epilepsy...