Most people now know about the negative effects of high blood sugar levels, but people with diabetes and other conditions also have to be aware of low blood sugar levels from severe hypoglycemia. The drug giant Eli Lilly & Company is about to get some new competition for the Glucagon injection emergency kit.
Amphastar Pharmaceuticals, Inc. is a much smaller company than Eli Lilly, but the company has announced that the U.S. Food and Drug Administration (FDA) has approved its Abbreviated New Drug Application (aNDA) for Glucagon 1mg for Injection Emergency Kit.
According to Amphastar, the newly approved synthetic peptide product is the bioequivalent and therapeutically equivalent to Lilly’s Glucagon Emergency Kit for Low Blood Sugar. This treatment has a recombinant DNA (rDNA) origin. This is what is a standard of a care for diabetic patients treated with insulin have either passed out or cannot take some form of sugar by mouth. Amphastar’s latest announcement also noted that this was the first-ever FDA approval of a generic version of rDNA Glucagon.
Inflammation Guide looks for news that may impact patients’ lives and how to live best with inflammation. In this instance of the Glucagon kit, the new competition from a bioequivalent is likely to end up the same as generics for pharmaceuticals with a result of lower prices and better access. Amphastar is planning to launch its Glucagon for Injection Emergency Kit within two months.
While Glucagon is indicated for the treatment of severe hypoglycemia, it is also used as a diagnostic aid. The diagnostic use is during x-rays of the stomach and bowels.
This latest release also indicated how large the sales of IQVIA are for Eli Lilly’s Glucagon Emergency Kit for Low Blood Sugar, 1 mg in the United States: $144 million, and the total sales of brand products containing glucagon for injection were $306 million for the 12-month period that ended on September 30, 2020.
Amphastar’s press release contains additional data on Glucagon and other pipeline drugs, and the American Diabetes Association (ADA) has additional details on severe hypoglycemia and Glucagon.