Post by icemandios on Aug 23, 2021 12:42:22 GMT
Xeris Pharmaceuticals Announces Approval of Supplemental New Drug Application (sNDA) of Gvoke® Kit for the Treatment of Severe Hypoglycemia
First ready-to-use liquid glucagon available in a single-dose vial and syringe kit for rescue
Gvoke HypoPen®, Gvoke® PFS, and Gvoke® Kit – three different administration options to accommodate patients’ preferences
Gvoke Kit eliminates the need for reconstitution
Gvoke Kit availability anticipated in early Q1 2022
Xeris Pharmaceuticals, Inc. (Nasdaq: XERS), a pharmaceutical company leveraging its novel formulation technology platforms to develop and commercialize ready-to-use injectable drug formulations, today announced that its supplemental new drug application (sNDA) of Gvoke® Kit was approved by the Food and Drug Administration (FDA) for the treatment of severe hypoglycemia in pediatric and adult patients with diabetes ages 2 years and above. Gvoke Kit will be available as a 1 mg/0.2 mL single dose vial and syringe kit. Gvoke Kit contains one (1) single-dose sterile syringe with markings for 0.1 mL (0.5 mg pediatric dose) and 0.2 mL (1 mg adult dose), and one single-dose vial containing 0.2 mL of solution. With this FDA approval, Xeris will begin manufacturing scale up immediately, and therefore anticipates Gvoke Kit availability early in the first quarter of 2022.
“Offering three different administration options - Gvoke HypoPen®, Gvoke® PFS, and Gvoke ® Kit, allows for greater patient choice in a ready-to-use rescue product for the approximately 6.8 million people in the U.S. who rely on insulin and are at-risk of a severe hypoglycemic event. These innovative formats provide the reliability of a ready-to-use liquid glucagon while offering multiple administration options for patients and caregivers,” said Paul R. Edick, Chairman and CEO of Xeris. “In particular for patients or caregivers who prefer to draw up their Gvoke rescue dose using a vial and syringe, Gvoke Kit reduces the number of steps by eliminating reconstitution - the most common mistake in correctly administering the conventional glucagon kit.”
The sNDA approval was supported by a pharmacokinetic study demonstrating bioequivalence of a 1 mg Gvoke dose administered via a vial and syringe kit (Gvoke Kit) to that of 1 mg Gvoke administered as a pre-filled syringe (Gvoke PFS).
ABOUT Gvoke® (US) /Ogluo® (EU)
Gvoke® PFS and Gvoke HypoPen® (glucagon injection), the first prescription, ready-to-use, pre-mixed, pre-measured glucagon injection, were approved by the FDA in September 2019 for use in the United States. Gvoke is indicated for the treatment of severe hypoglycaemia in paediatric and adult patients with diabetes ages 2 years and above. Ogluo received a positive opinion from the European Medicines Agency’s (EMA) Committee for Medicinal Products for Human Use (CHMP) in December 2020 and the European Commission (EC) granted the marketing authorisation on 11 February 2021. The United Kingdom’s Medicines and Healthcare products Regulatory Agency (MHRA) approved Ogluo® (glucagon) injection on April 29, 2021. Ogluo is indicated for the treatment of severe hypoglycaemia in adults, adolescents, and children aged 2 years and over with diabetes mellitus. In August 2021, the FDA approved Gvoke Kit, the first ready-to-use glucagon available in a single-use vial and single-use syringe kit for rescue.
First ready-to-use liquid glucagon available in a single-dose vial and syringe kit for rescue
Gvoke HypoPen®, Gvoke® PFS, and Gvoke® Kit – three different administration options to accommodate patients’ preferences
Gvoke Kit eliminates the need for reconstitution
Gvoke Kit availability anticipated in early Q1 2022
Xeris Pharmaceuticals, Inc. (Nasdaq: XERS), a pharmaceutical company leveraging its novel formulation technology platforms to develop and commercialize ready-to-use injectable drug formulations, today announced that its supplemental new drug application (sNDA) of Gvoke® Kit was approved by the Food and Drug Administration (FDA) for the treatment of severe hypoglycemia in pediatric and adult patients with diabetes ages 2 years and above. Gvoke Kit will be available as a 1 mg/0.2 mL single dose vial and syringe kit. Gvoke Kit contains one (1) single-dose sterile syringe with markings for 0.1 mL (0.5 mg pediatric dose) and 0.2 mL (1 mg adult dose), and one single-dose vial containing 0.2 mL of solution. With this FDA approval, Xeris will begin manufacturing scale up immediately, and therefore anticipates Gvoke Kit availability early in the first quarter of 2022.
“Offering three different administration options - Gvoke HypoPen®, Gvoke® PFS, and Gvoke ® Kit, allows for greater patient choice in a ready-to-use rescue product for the approximately 6.8 million people in the U.S. who rely on insulin and are at-risk of a severe hypoglycemic event. These innovative formats provide the reliability of a ready-to-use liquid glucagon while offering multiple administration options for patients and caregivers,” said Paul R. Edick, Chairman and CEO of Xeris. “In particular for patients or caregivers who prefer to draw up their Gvoke rescue dose using a vial and syringe, Gvoke Kit reduces the number of steps by eliminating reconstitution - the most common mistake in correctly administering the conventional glucagon kit.”
The sNDA approval was supported by a pharmacokinetic study demonstrating bioequivalence of a 1 mg Gvoke dose administered via a vial and syringe kit (Gvoke Kit) to that of 1 mg Gvoke administered as a pre-filled syringe (Gvoke PFS).
ABOUT Gvoke® (US) /Ogluo® (EU)
Gvoke® PFS and Gvoke HypoPen® (glucagon injection), the first prescription, ready-to-use, pre-mixed, pre-measured glucagon injection, were approved by the FDA in September 2019 for use in the United States. Gvoke is indicated for the treatment of severe hypoglycaemia in paediatric and adult patients with diabetes ages 2 years and above. Ogluo received a positive opinion from the European Medicines Agency’s (EMA) Committee for Medicinal Products for Human Use (CHMP) in December 2020 and the European Commission (EC) granted the marketing authorisation on 11 February 2021. The United Kingdom’s Medicines and Healthcare products Regulatory Agency (MHRA) approved Ogluo® (glucagon) injection on April 29, 2021. Ogluo is indicated for the treatment of severe hypoglycaemia in adults, adolescents, and children aged 2 years and over with diabetes mellitus. In August 2021, the FDA approved Gvoke Kit, the first ready-to-use glucagon available in a single-use vial and single-use syringe kit for rescue.