CHICAGO & DUBLIN--(BUSINESS WIRE)-- Xeris Pharmaceuticals, Inc. (Nasdaq: XERS), a specialty pharmaceutical company leveraging its novel formulation technology platforms to develop and commercialize ready-to-use injectable and infusible drug formulations, today announced that the United Kingdom’s Medicines and Healthcare Regulatory Agency (MHRA) has approved Ogluo® (glucagon) injection for the treatment of severe hypoglycaemia in adults, adolescents, and children aged 2 years and over with diabetes mellitus.
In February, the European Commission (EC) approved Ogluo. As the EC decision was received after the end of the Brexit transition period, Xeris was required to complete a further administrative step in order to obtain a license in Great Britain. No re-examination of clinical data by MHRA was required. The marketing authorization is valid in the United Kingdom, all 27 countries of the European Union, Iceland, Norway, and Liechtenstein.
As previously stated, the Company is actively seeking a partner to commercialize Ogluo in the U.K., EU, and other regions, with a targeted fourth quarter 2021 launch in select EU countries.
ABOUT GVOKE/OGLUO
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 hypoglycemia in pediatric 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 authorization on 11 February 2021. Ogluo is indicated for the treatment of severe hypoglycaemia in adults, adolescents, and children aged 2 years and over with diabetes mellitus.
INDICATION AND IMPORTANT SAFETY INFORMATION FOR GVOKE
Gvoke is indicated for the treatment of severe hypoglycaemia in adult and paediatric patients with diabetes ages 2 years and above.
IMPORTANT SAFETY INFORMATION
Contraindications
Gvoke is contraindicated in patients with pheochromocytoma, insulinoma, and known hypersensitivity to glucagon or to any of the excipients in Gvoke. Allergic reactions have been reported with glucagon and include anaphylactic shock with breathing difficulties and hypotension.
Warnings and Precautions
Gvoke is contraindicated in patients with pheochromocytoma because glucagon may stimulate the release of catecholamines from the tumor. If the patient develops a dramatic increase in blood pressure and a previously undiagnosed pheochromocytoma is suspected, 5 to 10 mg of phentolamine mesylate, administered intravenously, has been shown to be effective in lowering blood pressure.
In patients with insulinoma, administration of glucagon may produce an initial increase in blood glucose; however, Gvoke administration may directly or indirectly (through an initial rise in blood glucose) stimulate exaggerated insulin release from an insulinoma and cause hypoglycemia. Gvoke is contraindicated in patients with insulinoma. If a patient develops symptoms of hypoglycemia after a dose of Gvoke, give glucose orally or intravenously.
Allergic reactions have been reported with glucagon. These include generalized rash, and in some cases, anaphylactic shock with breathing difficulties and hypotension. Gvoke is contraindicated in patients with a prior hypersensitivity reaction.
Gvoke is effective in treating hypoglycemia only if sufficient hepatic glycogen is present. Patients in states of starvation, with adrenal insufficiency or chronic hypoglycemia, may not have adequate levels of hepatic glycogen for Gvoke administration to be effective. Patients with these conditions should be treated with glucose.
Necrolytic migratory erythema (NME), a skin rash commonly associated with glucagonomas has been reported post-marketing following continuous glucagon infusion and resolved with discontinuation of the glucagon. Should NME occur, consider whether the benefits of continuous glucagon infusion outweigh the risks. Glucagon administered to patients with glucagonoma may cause secondary hypoglycemia.
Adverse Reactions
Most common (≥5%) adverse reactions associated with Gvoke are nausea, vomiting, injection site edema (raised 1 mm or greater), and hypoglycemia.
Drug Interactions
Patients taking beta-blockers may have a transient increase in pulse and blood pressure when given OGLUO. In patients taking indomethacin, Gvoke may lose its ability to raise blood glucose or may even produce hypoglycemia. Gvoke may increase the anticoagulant effect of warfarin.
Please see full Prescribing Information for Gvoke on www.xerispharma.com. Manufactured for Xeris Pharmaceuticals, Inc. by Pyramid Laboratories Inc., Costa Mesa, CA 92626.
About Glucagon
Glucagon is a metabolic hormone secreted by the pancreas that raises blood glucose levels by causing the liver to rapidly convert glycogen (the stored form of glucose) into glucose, which is then released into the bloodstream. Glucagon and insulin are two critical hormones in a glycemic control system that keep blood glucose at the right level in healthy individuals. In people with diabetes who are dependent on insulin, this control system is disrupted, and insulin must be injected to avoid high levels of blood glucose (hyperglycemia). The opposite effect, or low blood glucose (hypoglycemia), is also prevalent in this population due to dysregulated glucagon secretion. Severe hypoglycemia is a serious condition and can lead to seizures, coma, potential brain injury and, if untreated, death.
Glucagon is the standard of care for treating severe hypoglycemia. According to the American Diabetes Association, glucagon should be prescribed for all individuals at increased risk of clinically significant hypoglycemia, defined as blood glucose