Zealand Pharma, an international biotechnology company, has gained FDA approval for its dasiglucagon injection for the treatment of severe hypoglycemia.
The injection, being marketed as Zegalogue, can be used to treat diabetes patients who are at least six years old. It will be made available as an auto injector or in a prefilled syringe.
“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,” Emmanuel Dulac, president and CEO of Zealand Pharma, said in a prepared statement. “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’s approval was based on three different placebo-controlled studies.
“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 Jeremy Pettus, MD, assistant professor of medicine at the University of California San Diego.