Eli Lilly & Company (LLY - Free Report) 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 - Free Report) , Johnson & Johnson (JNJ - Free Report) and Merck (MRK - Free Report) 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.
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