Xeris Pharma’s low blood sugar treatment wins FDA approval

(Reuters) – The U.S. Food and Drug Administration has approved Xeris Pharmaceuticals Inc’s glucagon pen that aims to treat severely low sugar levels in diabetes patients, the drugmaker said on Tuesday.

The condition, called hypoglycemia, can cause acute cognitive impairment. A mild or moderate fall in sugar levels, when left untreated, can result in cardiovascular disease, seizure, coma, and even death.

Gvoke, Xeris’ glucagon pen is an pre-filled device with liquid stable form of glucagon. It won approval for use in diabetes patients, aged 2 years and above.

Long-term use of insulin can sometimes lead to side effects, including hypoglycemia. Severe hypoglycemia typically occurs in diabetics on insulin treatment.

There are 5.6 million type 1 and type 2 diabetics who are taking insulin and anyone on insulin should have glucagon handy, Chief Executive Officer Paul Edick said.

“Just about everyone who is a diabetic is going to have frequent low blood sugar, most of them once or twice a year are going to have a severe episode that needs rescue.”

Eli Lilly and Co’s Baqsimi was approved to treat hypoglycemia by the U.S. FDA in July, making it the first approved non-injectable glucagon therapy for the emergency treatment of the condition.

Glucagon is a hormone produced by the pancreas that is responsible for raising the concentration of glucose and fatty acids in the bloodstream.

Injectable form of glucagon, standard of care for treating hypoglycemia, has been approved for use in the United States for several decades.