FDA Adcom Votes Against Lilly-Boehringer Ingelheim’s Jardiance in Type 1 Diabetes
The U.S. Food and Drug Administration (FDA) Endocrinologic and Metabolic Drugs Advisory Committee (EMDAC) met to discuss the benefits of Eli Lilly and Company and Boehringer Ingelheim’s Jardiance (empagliflozin) in type 1 diabetes. It was approved in 2014 in doses of 10 mg and 20 mg for type 2 diabetes. The 2.5 mg dose is being evaluated as an adjunct to insulin for adults with type 1 diabetes.
The advisory committee (Adcom) voted 14 to 2 that the benefits of the drug did not outweigh the risks to support approval. The FDA is not obligated to follow the recommendation of their adcoms, but typically do.
Empagliflozin is an SGLT2 inhibitor. Other drugs on the market in this category include Johnson & Johnson’s Invokana and AstraZeneca’s Farxiga. They lower blood sugar by increasing glucose excretion through urine. But the class of drug has been linked to the risk of diabetic ketoacidosis (DKA) at higher doses. DKA is a complication of type 1 diabetes and can be life threatening. DKA results in a type of acid called ketones, building up in the body.
“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 Mohamed Eid, vice president, Clinical Development & Medical Affairs, Cardio-Metabolism & Respiratory Medicine, Boehringer Ingelheim. “We continue to believe the totality of data from the EASE program indicates a favorable benefit-risk profile for empagliflozin 2.5 mg in adults with type 1 diabetes and look forward to continuing to work with the FDA in this review process.”
The supplemental New Drug Application (sNDA) leveraged data from the EASE Phase III program. This trial found that the 2.5 mg Farxiga in combination with insulin gave a statistically significant decrease in A1C levels compared to insulin given with a matched placebo in adults with type 1 diabetes. Secondary endpoints showed weight loss and a drop in systolic blood pressure.
Adverse events with similar to patients receiving the drug were similar to those seen in the insulin-plus-placebo group. The companies indicate that the number of diabetic ketoacidosis events was comparable between the two arms of the study.
“The EASE clinical trial data provides important information supporting the potential role of empagliflozin 2.5 mg for adults with type 1 diabetes,” said Jeff Emmick, vice president, Product Development, for Lilly. “Today, less than one third of people with type 1 diabetes in the U.S. consistently meet target blood sugar levels with insulin, putting them at increased risk for long-term complications. We are committed to participating in the ongoing dialogue around improving patient health and treatment options for this community.”
The adcom suggested that at least one more study, with a larger patient population, should be conducted to evaluate the safety risks. Jack Yanovski, with the Hatfield Clinical Research Center, National Institute of Child Health and Human Development, who serves on the panel, told Reuters that if the drug was adequately studied, it had the potential to be a very effective and relatively safe medication.