Zealand Pharma Announces FDA Approval of Zegalogue (dasiglucagon) injection, for the Treatment of Severe Hypoglycemia in People with Diabetes - Seite 2

“The U.S. FDA approval of Zegalogue is an exciting achievement for both patients and Zealand,” said Emmanuel Dulac, President and CEO 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. We are committed to helping people with diabetes manage the potential consequences of their disease and look forward to making Zegalogue available in the U.S. in June.  Field sales, market access and medical teams, along with comprehensive patient support services, are in place to maximize awareness to healthcare providers and preparedness to patients affected by severe hypoglycemia.” 

The FDA approval was based on efficacy results from three randomized, double-blind, placebo-controlled multicenter Phase 3 studies of Zegalogue in children aged 6 to 17 and in adults with type 1 diabetes. The primary efficacy endpoint for all three studies was time to plasma glucose recovery (treatment success), defined as an increase in blood glucose of ≥20 mg/dL from time of administration, without additional intervention within 45 minutes. The primary endpoint was successfully achieved across the adult and pediatric studies with a significantly faster median time to blood glucose recovery of only 10 minutes following Zegalogue administration compared to 30-45 minutes placebo. In the main Phase 3 adult trial 99% of patients recovered within 15 minutes.  

In these studies, the most common adverse events reported (≥2%) were nausea, vomiting, headache, diarrhea, and injection site pain in adults; and nausea, vomiting, headache, and injection site pain in pediatrics.

Conference Call Details

Zealand Pharma will host a conference call and webcast on Tuesday, March 23 at 1pm CET (8am ET). The conference call will be conducted in English, and the dial-in numbers are:

Denmark, Copenhagen..................	[phone]
Denmark, tollfree.........................	[phone]
France, Paris................................	[phone]
Netherlands, Amsterdam...............	[phone]
United Kingdom...........................	[phone]
United States..............................	[phone]
International.............................	[phone]
Confirmation Code: ......................	4878776

A live webcast of the call, including an accompanying slide presentation, will be available via the following link, https://edge.media-server.com/mmc/p/h87ikkyn, and will be accessible on the Investor section of Zealand’s website (https://www.zealandpharma.com/investor-relations). Due to increased demand of conference call services, it could take longer to be connected to the call. Participants are advised to register for the webcast 30 minutes before the scheduled start, if possible. An archive of today's webcast will be available on Zealand’s website for 60 days following the call.