September 10, 2019 / 3:50 PM / a month ago

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 therapy 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.

The company said it intends to price both pre-filled syringe and autoinjector versions of Gvoke at parity to current glucagon products.

Eli Lilly and Co’s non-injectable glucagon therapy Baqsimi, approved in July has a list price of $280.80 for a one-pack and $561.60 for a two-pack.

Xeris plans on making the pre-filled syringe available in 4-6 weeks and the autoinjector in 2020.

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.”

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.

Reporting by Aakash Jagadeesh Babu, Manojna Maddipatla and Saumya Sibi Joseph in Bengaluru; Editing by Shailesh Kuber

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