Committee rejects Boehringer & Lilly drug for type 1 diabetes

The U.S. Food and Drug Administration (FDA) advisory committee EMDAC voted 14 to 2 that the benefits of empagliflozin 2.5 mg do not outweigh the risks to support approval as an adjunct to insulin for adults with type 1 diabetes.

Jardiance (empagliflozin) 2.5 mg is an SGLT2 inhibitor developed by Boehringer Ingelheim and Eli Lilly. It is currently aprroved in type 2 diabetes treatment.

“It is important to emphasise that we owe it to the patients with type 1 diabetes to do this right and provide sufficient evidence to know that we are offering them a benefit and to well characterise the risks, and I think doing a study with 241 patients [in each arm] probably doesn’t quite meet that bar,” Brendan M. Everett, MD, MPH, FACC, FAHA, assistant professor of medicine and director of general cardiology inpatient service at Brigham and Women’s Hospital and Harvard Medical School, said after his “no” vote.

In discussing the statistical efficacy of the drug, the FDA stated that the statistically significant between-group HbA1c difference of –0.26% was attributable to a 0.2% HbA1c increase in the placebo group and a –0.05% decrease in the empagliflozin 2.5 mg group. Additionally, the “numerically small benefit” in body weight reduction and systolic BP reduction did not rise to significance, and there was no benefit in reducing hypoglycemic events.

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“We see today’s meeting as an important means of elevating the discussion around the challenges of managing blood sugar levels for those with type 1 diabetes and the need for new treatment options,” said Dr Mohamed Eid, VP Clinical Development & Medical Affairs, Cardio-Metabolism & Respiratory Medicine, Boehringer Ingelheim.

In March, the FDA rejected sotagliflozin (Zynquista, Sanofi and Lexicon). In July, the agency declined to expand the indication for another SGLT2 inhibitor, dapagliflozin (Farxiga, AstraZeneca), for use in type 1 diabetes.

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