Xeris Pharmaceuticals, Inc. announced today that its new drug application (NDA) for its ready-to-use, room-temperature stable liquid glucagon rescue pen for the treatment of severe hypoglycemia in people with diabetes has been accepted for review by the U.S. Food and Drug Administration (FDA).
The FDA has assigned a Prescription Drug User Fee Act (PDUFA) goal date for completion of the review of the glucagon rescue pen NDA of June 10, 2019.
The issuance of a PDUFA plays an important role in expediting the drug approval process.
“The FDA acceptance of our NDA for review, is an important milestone for Xeris,” said Paul R. Edick, chairman, and chief executive officer of Xeris Pharmaceuticals. “If approved, the Xeris glucagon rescue pen would be the first ready-to-use, liquid-stable glucagon in an auto-injector to treat severe hypoglycemia.”
He explains that compared to the current glucagon rescue option for people with diabetes who are at risk for severe hypoglycemia, the Xeris glucagon rescue pen would eliminate the need for reconstitution and dramatically simplify the preparation and administration process of the medicine.
The NDA is based on positive results from multiple Phase 3 clinical trials of the efficacy, safety, and utility of the Xeris glucagon rescue pen auto-injector in treating severe hypoglycemia when compared with currently marketed glucagon emergency kits among adults, children and adolescents with type 1 diabetes.
About Severe Hypoglycemia
Glucagon is the standard of care for treating severe hypoglycemia. According to the American Diabetes Association (ADA), glucagon should be prescribed for all individuals at increased risk of clinically significant hypoglycemia, defined as blood glucose <54 mg/dL (3.0 mmol/L).
Hypoglycemic events of any severity are a daily concern for people with diabetes. Mild or moderate hypoglycemia can occur multiple times a month.
Severe hypoglycemia is characterized by severe cognitive impairment, requiring external assistance for recovery, and can be extremely frightening for patients and caregivers.
Severe hypoglycemia can result in cardiovascular disease, seizure, coma, and if left untreated, death. These severe hypoglycemic events can occur multiple times a year. Such events require emergency assistance from another person or caregiver such as a family member, friend, or co-worker.
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Xeris Pharmaceuticals Announces FDA Acceptance for Review of NDA for Its Ready-to-Use Glucagon Rescue Pen. (2018, October 23). Business Wire. Retrieved: October 25, 2018 from https://www.businesswire.com/news/home/20181023005475/en/Xeris-Pharmaceuticals-Announces-FDA-Acceptance-Review-NDA