FDA Approves First Generic Drug for Severe Hypoglycemia

January 06, 2021 - FDA recently approved the first generic drug for the treatment of severe hypoglycemia, which may occur in patients with diabetes mellitus. 

Amphastar Pharmaceutical’s generic of glucagon was approved for injection USP, 1 milligram/vial packaged in an emergency kit, for the treatment of extremely low blood sugar. The drug was also indicated as a diagnostic aid in the radiologic examination of the stomach and parts of the intestines and bowel. 

FDA noted that the generic glucagon is a synthetic version of human glucagon.

“Glucagon for injection has been approved for use in the U.S. for more than 20 years, but until today, there has been no approved generic of this important drug that can save the lives of people who may experience the serious condition of very low blood sugar,” Sally Choe, PhD, director of the Office of Generic Drugs in FDA’s Center for Drug Evaluation and Research, said in the announcement. 

The recent FDA approval supports the development of complex generic drugs to improve competition and access to more affordable medicines.

Last year, FDA approved the first glucagon therapy for the emergency treatment of severe hypoglycemia that can be administered without an injection.

Eli Lilly & Company’s Baqsimi was approved for a single-use dispenser that can be given to an individual suffering from a severe hypoglycemic episode. The product increases blood sugar levels in the body by stimulating the liver to release stored glucose into the bloodstream, FDA said. 

The agency determined that Amphastar’s product is bioequivalent and therapeutically equivalent to Eli Lilly’s Glucagon Emergency Kit for Low Blood Sugar, which has a recombinant DNA (rDNA)-origin.

Then in September 2019, FDA approved a ready-to-use liquid glucagon for the treatment of severe hypoglycemia in pediatric and adult patients with diabetes aged two years and older.

The drug, GVOKE, can be administered in two doses through a prefilled syringe, which quickens the treatment time in the event of severe hypoglycemia. Pediatric patients will receive a 0.5 milligram/0.1-milliliter dose and adolescent and adult patients will receive 1 milligram/0.2 milliliter.

Severe hypoglycemia is when a patient’s blood sugar falls to a level where the individual needs assistance. It generally occurs in people with diabetes who are using insulin treatment. 

Glucagon causes the liver to increase blood sugar levels and slows down movement of the gastrointestinal tract. But some side effects associated with glucagon for injection may include nausea and vomiting, a temporary increase in heart rate, and swelling of the injection site, FDA said. 

Until now, glucagon had been included on the FDA’s list of off-patent, off-exclusivity drug products without an improved generic. The recent approval furthers the efforts under the FDA’s Generic Drug User Fee Amendments (GDUFA) and Drug Competition Action Plans.

GDUFA supports the development of complex generic drug products by allowing companies to meet with FDA as part of its pre-Abbreviated New Drug Application (ANDA) program , FDA stated. 

"This approval is yet another milestone for the Company and marks the first-ever FDA approval of a generic version of rDNA Glucagon. Using a dedicated process and sophisticated characterization technology, we demonstrated to the Agency that our highly purified synthetic peptide product is bioequivalent and therapeutically equivalent to the reference listed drug (RLD), which is an rDNA product,” Jack Zhang, Aphastar’s CEO and president said in a statement released after the approval.

“This further highlights Amphastar’s considerable abilities to bring complex generic drugs to the market, and more specifically, our strong peptide capabilities,” Zhang concluded.