FDA Rejects Boehringer Ingelheim, Eli Lilly Drug for Type 1 Diabetes

Xconomy Europe — 

A type 2 diabetes drug marketed by Boehringer Ingelheim and Eli Lilly has fallen short of a bid to expand the medicine’s approval to patients who have type 1 diabetes.

The FDA on Friday rejected the application for the drug, empagliflozin (Jardiance), for use in addition to insulin as a treatment for type 1 diabetes in adults. Boehringer Ingelheim and Lilly (NYSE: LLY) did not detail the agency’s rationale for denying the application. Last November, an FDA advisory committee voted 14 to 2 against recommending approval of the drug, saying the drug’s benefits do not outweigh its safety risks.

Type 1 diabetes is an autoimmune disorder that leads to the destruction of pancreatic beta cells. The loss of these cells impairs the production of insulin, the hormone that regulates blood sugar. Abnormally high levels of blood sugar can lead to serious health complications. Empagliflozin is part of a drug class called SLGT2 inhibitors, which lower blood sugar by increasing the amount of glucose excreted in urine. These drugs don’t address the underlying cause of type 1 diabetes, and are associated with risk of diabetic ketoacidosis, a potentially life-threatening complication in which the blood becomes more acidic.

Empagliflozin was initially approved in 2014 as treatment, in addition to diet and exercise, for the more common type 2 diabetes. That decision covered 10 mg and 25 mg doses of the drug. For patients with type 1 diabetes, Boehringer Ingelheim and Lilly sought approval for a 2.5 mg dose of empagliflozin. In briefing documents filed prior to the advisory committee meeting, FDA reviewers wrote that the potential benefits of the drug are “small in magnitude.” The FDA staff added that the average patient in the pivotal study did not have high blood pressure, nor was obese, making the clinical relevance of the study’s results uncertain.

Empagliflozin was originally developed by Boehringer Ingelheim. In 2011, the privately held German company, which has US operations in Ridgefield, CT, entered a diabetes drugs partnership with Lilly. According to Lilly’s 2019 annual report the Jardiance family of drugs accounted for $944.2 million out of the company’s $22.3 billion in sales for the year. Empagliflozin sales that year were 43 percent higher than in 2018.

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