FDA Nod For First Generic Drug To Treat Severe Hypoglycemia

The U.S. Food and Drug Administration approved the first generic drug to treat severe hypoglycaemia or dangerously low blood sugar levels, which could occur in patients with diabetes mellitus and who are using insulin treatment.

Amphastar Pharmaceuticals’ generic glucagon for injection USP, 1 mg/vial, packaged in an emergency kit, is the first-ever FDA approval of a generic version of rDNA Glucagon. It is a synthetic version of human glucagon to treat severe hypoglycaemia.

Amphastar plans to launch this Glucagon for Injection Emergency Kit, which it previously referred to as AMP-001, within two months.

In severe hypoglycemia cases, blood sugar levels fall below the normal range where the patient becomes confused or unconscious, or suffers from other symptoms that require assistance from another person to treat.

While insulin lowers blood sugar levels by moving glucose from the bloodstream into the cells, Glucagon is a hormone that causes the liver to quickly increase blood sugar levels. This hormone also slows down movement of the gastrointestinal tract.

Amphastar’s glucagon for injection was determined by the FDA to be bioequivalent and therapeutically equivalent to Eli Lilly’s Glucagon Emergency Kit for Low Blood Sugar, which has a recombinant DNA (rDNA)-origin.

The FDA often prioritizes the review of submissions for generic drugs for which there are fewer than three approved generics.

In September 2019, the FDA had approved Gvoke, liquid glucagon, developed by Xeris Pharmaceuticals, for the treatment of severe hypoglycemia in diabetes patients of 2 years and older. Gvoke is the first glucagon product approved that can be administered via a pre-filled syringe (Gvoke PFS) or auto-injector-Gvoke HypoPen.

In July 2019, the FDA gave nod to the glucagon nasal powder Baqsimi from Eli Lilly to treat severe hypoglycaemia, which is normally treated with glucagon injection. Baqsimi is a powder administered into the nose, via an intranasal spray using a single-use dispenser.

Injectable glucagon has been approved for use in the U.S. for several decades, and the user has to first dissolve the glucagon powder in a liquid before it can be administered, a process which is complicated.

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