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FDA Verdict On XERS - Go Or No Go?

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Xeris Pharmaceuticals, Inc. (XERS) is a speciality pharma company developing ready-to-use injectable and infusible drugs, primarily for the treatment of Hypoglycemia or low blood sugar.

The company's lead product candidate, Gvoke HypoPen, is a liquid glucagon auto injector proposed for severe hypoglycemaia. This single-use auto-injector pen that comes in 0.5 mg and 1 mg doses is developed using the company's patented XeriSol technology.

A New Drug Application (NDA) for Gvoke is under FDA review, with a decision expected by September 10, 2019. If approved, the company plans to launch the product in the fourth quarter of 2019.

Xeris plans to submit Marketing Authorization Application (MAA) of Gvoke to European Medicines Agency (EMA) by the end of this year.

The company is presently investigating the usage of glucagon for treating hypoglycemia associated with different conditions.

Bariatric surgery can cause Post Bariatric Hypoglycemia (PBH), a condition of recurrent episodes of severe low blood sugar. A phase II study of glucagon to treat patients with PBH is going on. The first patient was enrolled in June 2019.

A phase II trial is underway to examine the use of intermittent glucagon administration prior to exercise, to mitigate the risk of Exercise-Induced Hypoglycemia.

Congenital Hyperinsulinism (CHI) is a genetic disorder causing severe, continous hypoglycemia in newborn babies and children. A phase II study is in progress to treat CHI with continuous infusion of glucagon.

Hypoglycemia-Associated Autonomic Failure (HAAF) is developed when persons with diabetes lose hypoglycemia awareness due to repeated episodes of chronic hypoglycemia. Xeris is carying out a phase II study of glucagon for continuous-infusion to patients with HAAF to restore hypoglycemia awareness.

Acute Repetitive Seizures (ARS), is a form of epilepsy in which the patient suffers a series of seizures within a short period of time. Xeris is developing an auto injectible form of diazepam, the approved drug for ARS, using XeriSol technology. Diazepam is currently available as rectal gel, which is difficult to use. A phase I study of this novel formulation revealed positive results, the companyy said in May this year. Xeris plans to start phase II trial by the end of this year. Orphan drug desigantion was granted to this new formulation by the FDA in 2016.

Dravet syndrome, another form of epilepsy, is a genetic brain disorder that stays for lifelong. Xeris had received orphan drug designation to the new auto injectable form of diazepam for the treatment of dravet syndrome in 2018.

Another product candidate in the pipeline is Pramlintide-insulin, pre-clinical studies of which are underway for controlling blood sugar level in Type 1 and 2 diabetes patients. Pramlintide resembles the human hormone Amylin, that work with insulin to maintain blood sugar levels normal.

If all goes well, Gvoke HypoPen, the company's first ever product will get FDA approval tomorrow, thrusting the company to new heights.

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