Eli Lilly & Company (LLY - Free Report) announced that the FDA has granted Fast Track status to its diabetes drug, Jardiance to improve survival and prevent hospitalization for heart failure in patients who have had a heart attack.
The prestigious designation to the SGLT-2 inhibitor was based on data from the EMPACT-MI study, which is evaluating Jardiance to prevent heart failure and reduce the risk of mortality in adults with and without diabetes who have had an acute myocardial infarction, commonly known as heart attack. Lilly and partner Boehringer Ingelheim are conducting the study in partnership with Duke Clinical Research Institute.
The FDA provides a Fast Track designation to help the development and faster review of drugs, which treat serious and unmet medical conditions. Heart attacks are the leading cause of heart failure and are associated with a high risk of death and there is significant need for treatment options to help improve outcomes.
Please note that Jardiance is already approved to reduce the risk of cardiovascular death in adults with type II diabetes based on data from the EMPA-REG OUTCOME study.
Lilly’s stock has risen 14.2% this year so far against an increase of 0.4% for the industry.
The EMPACT-MI study is part of Jardiance’s ENPOWER clinical program, which is studying the impact of Jardiance on major clinical cardiovascular and renal outcomes in a spectrum of cardio-renal-metabolic conditions.
The ENPOWER clinical program includes EMPEROR-Reduced and EMPEROR-Preserved studies. These studies are evaluating Jardiance for reducing the risk of cardiovascular death and hospitalization for heart failure in adults with chronic heart failure with reduced or preserved ejection fraction, respectively. Meanwhile, the program also includes the EMPERIAL studies (EMPERIAL-Reduced and EMPERIAL-Preserved) to see whether Jardiance can help improve the everyday lives of people living with chronic heart failure. The EMPA-KIDNEY study is evaluating Jardiance to reduce the risk of kidney disease progression and cardiovascular death in adults with chronic kidney disease.
Jardiance is a key top-line driver for Lilly. Its sales surged 43% year over year to $529.5 million in the first half of 2020, up 22% year over year driven by increased demand trends within the SGLT2 class of diabetes medicines in the United States and increased volume outside the United States.
However, we note that 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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