Xeris Pharmaceuticals announced it has submitted a ready-to-use glucagon pen to the FDA for approval. Earlier this year, the drugmaker announced it had successfully completed two Phase III studies and a separate usability study showing that its Glucagon Rescue Pen was effective and could be administered by users to treat hypoglycemia in real-world conditions.
The submission was announced during the company’s earnings report for the second quarter of 2018.
If Xeris’ pen gains FDA approval, it would become the first room temperature-stable liquid glucagon on the market. Current formulations of glucagon must be mixed before being injected, a step that adds a layer of complication to an already fraught process for treating severe hypoglycemia. Too often, people will not administer glucagon during a severe bout of hypoglycemia and instead wait for medical professionals to provide assistance. This can increase the risk of complications or even fatalities from hypoglycemia.
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Xeris has been working for several years to bring its novel formulation of glucagon to market, and it has cleverly utilized the FDA’s Orphan Drug Designation (ODD) program to do it. The ODD program is designed to encourage drugmakers to develop treatments for rare diseases or conditions that may affect fewer than 200,000 people in the United States. That designation wouldn’t apply for hypoglycemia from insulin therapy, as the American Diabetes Association estimates there are some 6 million people on insulin therapy in the United States. Instead, Xeris applied for the ODD designation for the much rarer instances of severe hypoglycemia caused by conditions when the body naturally produces too much insulin or fails to produce the insulin it produces. Drugmakers who win ODD status are rewarded with incentives like a tax credit towards paying for clinical trials, extended market exclusivity for the product, and some fast-track status with the FDA.
If Xeris’ liquid glucagon pen is approved by the FDA, it could open up a regulatory lane for the approval of a dual-hormone artificial pancreas pump system. The currently approved formulations of glucagon can’t work in an insulin and glucagon pump system. An FDA approval for Xeris’ pen might advance the fortunes of Beta Bionics, the company which has been working the longest to bring a dual-hormone pump to market. In May 2018, Beta Bionics published notice that it had completed a clinical trial in which 20 participants used its dual-hormone pump in real-world conditions for 11 days. The pump utilized Xeris’ liquid glucagon formulation.
For years, there had been little innovation when it came to glucagon treatment for severe hypoglycemia. That has changed in recent months, however, as Xeris is not even the first drugmaker to ask the FDA for approval for a novel glucagon formulation in this calendar year. In July, Lilly announced that it had submitted its nasal spray glucagon to the FDA for approval. Also, earlier this year, Protomer took home first prize in the T1D Diabetes Innovation Challenge for its work on a glucagon molecule which would automatically activate in the bloodstream when blood sugar levels were dropping (disclosure – Glu is published by T1D Exchange). With the recent news, it seems likely that the days of mix-and-inject glucagon are numbered.