Xeris' Severe Hypoglycemia Drug Snags FDA Approval

FDA Approval

Chicago-based Xeris Pharmaceuticals won approval from the U.S. Food and Drug Administration (FDA) for its Gvoke (glucagon) injection as a treatment for severe hypoglycemia in pediatric and adult patients with diabetes ages 2 years and above. The approval marks the first commercial product for Xeris.

For diabetic patients, there is a risk of developing low blood sugar or hypoglycemia and Xeris believes its auto-injector will benefit patients who experience this condition. Severe hypoglycemia is an emergency situation in type 1 and type 2 diabetes patients. If untreated, it can have serious consequences, including passing out, seizures, coma and death. In what is being billed by Xeris as the first ready-to-use liquid glucagon option, Gvoke will be available as both a prefilled syringe and an auto-injector in order to provide quick treatment for patients in need. Injectable glucagon has been available for years, but the process takes some time. Gvoke’s premade formula cuts down on the amount of preparation time traditionally needed to get the drug into a patient’s body. The newly-approved drug is available in two doses, a .5 mg/0.1 mL dose for pediatric patients and a 1 mg/0.2 mL dose for adolescent and adult patients.

Paul R. Edick, chairman and chief executive officer of Xeris, called the approval of Gvoke an important milestone for the diabetes community. Edick said Gvoke is the first “premixed, prefilled, and premeasured liquid glucagon to effectively treat severe hypoglycemia in both adults and children with diabetes.” Gvoke will be introduced as both a prefilled syringe and as an auto-injector. Edick said the prefilled syringe will be available within four to six weeks and the auto-injector will be available to patients in 2020.

The FDA’s approval is based on positive results from three Phase II clinical trials evaluating the efficacy, safety and utility of Gvoke. During clinical testing, Gvoke was compared with conventional glucagon emergency kits used among adults and children with type 1. The studies demonstrated 100% treatment success in children and 99% treatment success in adults. When looking at usability, Xeris’ research showed that both the prefilled syringe and the auto-injector, known as the HypoPen, demonstrated nearly 100% success rates in administering a full dose of glucagon. The most common adverse reactions in adults were nausea, vomiting, injection site edema, and headache. In pediatric and adolescent patients, the most common adverse reactions were nausea, hypoglycemia, vomiting, headache, abdominal pain, hyperglycemia, injection site reactions and discomfort, and urticaria. Approximately 80% of side effects seen were mild, the company said.

As an easy-to-use hypoglycemia option, Xeris’ Gvoke will compete with Eli Lilly’s Baqsimi, a glucagon nasal powder approved in July. Baqsimi is the only nasally-dosed glucagon on the market. Baqsimi comes in an already-prepared single-use dispenser. Denmark-based Zealand A/S is also close to filing a New Drug Application for its hypoglycemia treatment dasiglucagon, which will also be administered in an auto-injector.

In June, Xeris announced positive results from a global Phase III trial of Gvoke head-to-head against Novo Nordisk’s GlucaGen HypoKit. The results were comparable.

Gvoke is contraindicated in patients with pheochromocytoma, insulinoma, and patients with a known hypersensitivity to glucagon or to any of the ingredients in Gvoke.

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