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Lilly's (LLY) Jardiance Heart Failure Study Meets Main Goal
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Eli Lilly and Company (LLY - Free Report) and partner Boehringer Ingelheim announced that its EMPEROR-Preserved phase III study, which evaluated its type II diabetes drug, Jardiance in adults with heart failure with preserved ejection fraction (HFpEF) met the primary endpoint.
Top-line data from the study showed that Jardiance, a SGLT-2 inhibitor, significantly reduced the risk of the composite of cardiovascular death or hospitalization for heart failure versus placebo in patients with HFpEF, with and without diabetes. Lilly said that this is the first time that any medicine has improved outcomes in a study for HFpEF, which is the most challenging form of heart failure to treat. Detailed data from the study will be presented at the European Society of Cardiology (ESC) Congress to be held next month. The companies plan to file regulatory submissions for the HFpEF indication this year.
Lilly’s shares have risen 39.4% this year so far compared with the industry’s increase of 10%.
Image Source: Zacks Investment Research
Please note that Lilly’s supplemental new drug application (sNDA) seeking approval for Jardiance for adults with heart failure with reduced ejection fraction (HFrEF), with and without diabetes is under review with the FDA. The sNDA for the HFrEF indication was based on data from the phase III EMPEROR-Reduced study, which showed that Jardiance is associated with a significant 25% relative risk reduction in time to cardiovascular death or hospitalization due to heart failure. Jardiance was approved for the HFrEF indication in Europe recently.
If approved for both HFrEF and HFpEF indications in the United States, Jardiance would become thefirstSGLT2 inhibitor, approved to treat full spectrum of heart failure patients regardless of ejection fraction.
Other than being a successful medicine to treat type II diabetes, Jardiance is also approved to reduce cardiovascular death in people with type II diabetes and cardiovascular disease. It is a key top-line driver for Lilly. Jardiance sales rose 17% to $312.0 million in the first quarter of 2021, driven by increased demand trends within the SGLT2 class of diabetes medicines in the United States and increased volume outside the United States. A phase III study on Jardiance for chronic kidney disease is ongoing.
Other SGLT2 inhibitors available in the market are J&J’s (JNJ - Free Report) Invokana, and AstraZeneca’s (AZN - Free Report) Farxiga/Forxiga. Farxiga was approved for the HFrEF indication in the United States and EU in 2020 while late-stage studies are ongoing for the HFpEF indication.
AbbVie’s stock has risen 8% this year so far. Estimates for 2021 earnings have increased from $12.59 to $12.60 per share in the past 60 days while that for 2022 have risen from $13.96 to $14.00 over the same period
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Zacks has released a Special Report to help you do just that, and today it’s free. Discover 7 special companies that look to gain the most from construction and repair to roads, bridges, and buildings, plus cargo hauling and energy transformation on an almost unimaginable scale.
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Lilly's (LLY) Jardiance Heart Failure Study Meets Main Goal
Eli Lilly and Company (LLY - Free Report) and partner Boehringer Ingelheim announced that its EMPEROR-Preserved phase III study, which evaluated its type II diabetes drug, Jardiance in adults with heart failure with preserved ejection fraction (HFpEF) met the primary endpoint.
Top-line data from the study showed that Jardiance, a SGLT-2 inhibitor, significantly reduced the risk of the composite of cardiovascular death or hospitalization for heart failure versus placebo in patients with HFpEF, with and without diabetes. Lilly said that this is the first time that any medicine has improved outcomes in a study for HFpEF, which is the most challenging form of heart failure to treat. Detailed data from the study will be presented at the European Society of Cardiology (ESC) Congress to be held next month. The companies plan to file regulatory submissions for the HFpEF indication this year.
Lilly’s shares have risen 39.4% this year so far compared with the industry’s increase of 10%.
Please note that Lilly’s supplemental new drug application (sNDA) seeking approval for Jardiance for adults with heart failure with reduced ejection fraction (HFrEF), with and without diabetes is under review with the FDA. The sNDA for the HFrEF indication was based on data from the phase III EMPEROR-Reduced study, which showed that Jardiance is associated with a significant 25% relative risk reduction in time to cardiovascular death or hospitalization due to heart failure. Jardiance was approved for the HFrEF indication in Europe recently.
If approved for both HFrEF and HFpEF indications in the United States, Jardiance would become thefirstSGLT2 inhibitor, approved to treat full spectrum of heart failure patients regardless of ejection fraction.
Other than being a successful medicine to treat type II diabetes, Jardiance is also approved to reduce cardiovascular death in people with type II diabetes and cardiovascular disease. It is a key top-line driver for Lilly. Jardiance sales rose 17% to $312.0 million in the first quarter of 2021, driven by increased demand trends within the SGLT2 class of diabetes medicines in the United States and increased volume outside the United States. A phase III study on Jardiance for chronic kidney disease is ongoing.
Other SGLT2 inhibitors available in the market are J&J’s (JNJ - Free Report) Invokana, and AstraZeneca’s (AZN - Free Report) Farxiga/Forxiga. Farxiga was approved for the HFrEF indication in the United States and EU in 2020 while late-stage studies are ongoing for the HFpEF indication.
Lilly currently has a Zacks Rank #3 (Hold).
A better-ranked large drugmaker is AbbVie (ABBV - Free Report) , which has a Zacks Rank #2 (Buy). You can see the complete list of today’s Zacks #1 Rank (Strong Buy) stocks here.
AbbVie’s stock has risen 8% this year so far. Estimates for 2021 earnings have increased from $12.59 to $12.60 per share in the past 60 days while that for 2022 have risen from $13.96 to $14.00 over the same period
Infrastructure Stock Boom to Sweep America
A massive push to rebuild the crumbling U.S. infrastructure will soon be underway. It’s bipartisan, urgent, and inevitable. Trillions will be spent. Fortunes will be made.
The only question is “Will you get into the right stocks early when their growth potential is greatest?”
Zacks has released a Special Report to help you do just that, and today it’s free. Discover 7 special companies that look to gain the most from construction and repair to roads, bridges, and buildings, plus cargo hauling and energy transformation on an almost unimaginable scale.
Download FREE: How to Profit from Trillions on Spending for Infrastructure >>