UK markets closed

FDA Panel Votes Against Lilly's Jardiance for Type I Diabetes

Zacks Equity Research

Eli Lilly & Company LLY announced an the FDA advisory committee has voted against the label expansion of its SGLT-2 inhibitor Jardiance (empagliflozin 2.5 mg) as an adjunct to insulin for adults with type I diabetes

The supplemental new drug application (sNDA) filed by Lilly and partner Boehringer Ingelheim is seeking approval for their type II diabetes medicine Jardiance, 2.5 mg, for type I diabetes under a separate brand name. The FDA’s Endocrinologic and Metabolic Drugs Advisory Committee (EMDAC) met to review data from the EASE phase III studies and voted 14-2, suggesting that the benefits of Jardiance 2.5 mg do not outweigh the risks to support approval for the indication.

Data from the EASE studies have shown that empagliflozin 2.5 mg plus insulin provided a statistically significant reduction in A1C versus plus placebo. Meanwhile, empagliflozin treatment led to reduction in weight and decrease in systolic blood pressure, which were the secondary endpoints. While the FDA usually follows the advice of its advisory panel, it is not always required to do so.

Year to date, Lilly’s shares have declined 2.5% against the industry’s increase of 3.6%.



Jardiance is a key top-line driver for Lilly. Its sales surged 45% to $676.2 million, driven by increased demand trends within the SGLT2 class of diabetes medicines in the United States and higher volume outside the United States.

Meanwhile, earlier this week, Lilly and partner Boehringer Ingelheim announced initiation of the first ever study to evaluate Jardiance in patients with and without type II diabetes hospitalized for acute heart failure and who have been stabilized. The aim of this study, known as EMPULSE, is to understand whether Jardiance has the potential to improve outcomes in this patient population. It is the sixth phase III study in the Jardiance heart failure program.

While the diabetes market holds immense commercial potential, it is pretty crowded with the presence of companies like Novo Nordisk A/S NVO, Johnson & Johnson JNJ and Merck MRK among others.

Lilly currently carries a Zacks Rank #3 (Hold). You can see the complete list of today’s Zacks #1 Rank (Strong Buy) stocks here.

Today's Best Stocks from Zacks

Would you like to see the updated picks from our best market-beating strategies? From 2017 through 2018, while the S&P 500 gained +15.8%, five of our screens returned +38.0%, +61.3%, +61.6%, +68.1%, and +98.3%.

This outperformance has not just been a recent phenomenon. From 2000 – 2018, while the S&P averaged +4.8% per year, our top strategies averaged up to +56.2% per year.

See their latest picks free >>

Want the latest recommendations from Zacks Investment Research? Today, you can download 7 Best Stocks for the Next 30 Days. Click to get this free report
Merck & Co., Inc. (MRK) : Free Stock Analysis Report
Novo Nordisk A/S (NVO) : Free Stock Analysis Report
Eli Lilly and Company (LLY) : Free Stock Analysis Report
Johnson & Johnson (JNJ) : Free Stock Analysis Report
To read this article on click here.
Zacks Investment Research