FDA advisory panel votes against approving empagliflozin 2.5mg

The US Food and Drug Administration Endocrinologic and Metabolic Drugs Advisory Committee (EMDAC) advises against marketing authorization of a low dose SGLT2 inhibitor, voting 14 to 2 that the benefits of empagliflozin 2.5mg do not outweigh the risks to support approval as an adjunct to insulin for adults with type 1 diabetes, citing a lack of adequate data to support evidence for safety and efficacy.

Empagliflozin 2.5mg is being developed by family-owned German drugmaker Boehringer Ingelheim and US partner Eli Lilly (NYSE: LLY). A separate brand name has been proposed for empagliflozin 2.5mg in type 1 diabetes. The drug is currently marketed under the Jardiance trade name at 10mg and 25mg doses and generated first-half 2019 sales of 1 billion euros ($1.1 billion), up 44.8% at currency-adjusted rates on the first half of 2018, for Boehringer.

“With about 40,000 Americans diagnosed with type 1 diabetes every year, 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, vice president, clinical development and medical affairs, Cardio-Metabolism & Respiratory Medicine, Boehringer Ingelheim Pharmaceuticals, Inc. “We continue to believe the totality of data from the EASE program indicates a favorable benefit-risk profile for empagliflozin 2.5mg in adults with type 1 diabetes and look forward to continuing to work with the FDA in this review process,” he added.