Lupin Gets USFDA Nod for Diabetes, Hypoglycaemia Drugs

Lupin Ltd. said Thursday it has received approval from the US Food and Drug Administration for its Abbreviated New Drug Applications for Liraglutide and Glucagon injections. Both products will be manufactured at the company’s injectables facility in Nagpur.

No launch timeline has been disclosed for either drug.

Liraglutide, a glucagon-like peptide-1 (GLP-1) drug used to improve glycaemic control in adults with type-2 diabetes, is the bioequivalent of Novo Nordisk’s Victoza. It is supplied in 18 mg/3 ml single-use prefilled pens, and had annual US sales of $458 million in the 12 months ended May, according to IQVIA data cited by the company.

Glucagon injection, used to treat severe hypoglycaemia in diabetic patients, is the bioequivalent of Eli Lilly’s formulation. It is available in 1 mg vials and has estimated annual US sales of $124 million.