Zealand Pharma Wins FDA Approval for Zegalogue Injection in Diabetic Hypoglycemia
10:17 AM EDT, 05/12/2021 (MT Newswires) -- Zealand Pharma (ZEAL) on Wednesday said that Zegalogue has been approved by the US Food and Drug Administration for the treatment of severe hypoglycemia in pediatric and adult patients with diabetes aged 6 years and above.
The FDA approval was based on efficacy results from three randomized, double-blind, placebo-controlled multicenter phase 3 studies which showed significantly faster median time to blood glucose recovery following Zegalogue administration compared with placebo, according to the biotechnology firm.
Zealand Pharma also said that it is planning to launch Zegalogue in the US in late June.
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