Xeris Pharmaceuticals Inc., submitted an NDA to the U.S. Food and Drug Administration yesterday for its Glucagon Rescue Pen, the company’s lead product for the treatment of severe hypoglycemia, a potentially life-threatening condition in people with diabetes.
If the pen is approved, it will be the first ready-to-use autoinjector to treat hypoglycemia.
Current glucagon formulations require patients to mix a liquid and powder in a syringe before injection.
Xeris has also presented positive phase 3 efficacy and safety data at American Diabetes Association’s 78th Scientific Sessions from two of its Phase 3 clinical studies of its ready-to-use Glucagon Rescue Pen in treating severe hypoglycemia in adults and children with Type 1 diabetes, as compared to the currently marketed Glucagon Emergency Kit.
The company also successfully completed their IPO in the second quarter and raised $89 million in net proceeds, which will fund multiple clinical programs, advance pre-clinical programs in other therapeutic areas, as well as build out our commercial organization in preparation for the commercial launch of the Glucagon Rescue Pen in the U.S.
“We are delighted to have submitted the NDA for our Glucagon Rescue Pen since [our] IPO,” said Paul R. Edick, chairman and Chief Executive Officer of Xeris Pharmaceuticals.
“Our NDA submission is a major milestone for Xeris and Glucagon Rescue Pen, which has the potential to be the preferred rescue treatment for severe hypoglycemia in people with diabetes,” he adds.
If the NDA is approved in the expected timeframe, Edick believes the company will have the first ready-to-use, room-temperature stable liquid glucagon formulation that can be administered without any preparation or reconstitution.