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Lilly's (LLY) Jardiance Gets FDA Approval for Heart Failure

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Eli Lilly and Company LLY and partner Boehringer Ingelheim announced that the FDA has granted approval to their SGLT-2 inhibitor, Jardiance for a form of heart failure.

The approval is for reducing the risk of cardiovascular death plus hospitalization for heart failure in adults with heart failure with reduced ejection fraction (HFrEF) regardless of whether they have type II diabetes.

The supplemental new drug application (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 in June.

Lilly’s shares have risen 50.9% this year so far compared with the industry’s increase of 20%.

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Jardiance has also been evaluated for another form of heart failure, heart failure with preserved ejection fraction (HFpEF). Last month, Lilly announced that its EMPEROR-Preserved phase III study, which evaluated Jardiance in adults HFpEF, met the primary endpoint.

Top-line data from the study showed that Jardiance 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 improved outcomes in a study for HFpEF, which is the most challenging form of heart failure to treat. The companies plan to file regulatory submissions for the HFpEF indication this year.

If approved for both HFrEF and HFpEF indications in the United States, Jardiance would become the first SGLT2 inhibitor, approved to treat the 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 36% to $356.5 million in the second 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. The approval for the HFrEF indication can boost sales higher in future quarters. A phase III study on Jardiance for chronic kidney disease is ongoing.

Other SGLT2 inhibitors available in the market are J&J’s JNJ Invokana, and AstraZeneca’s AZN 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 biotech is Regeneron REGN, which has a Zacks Rank #1 (Strong Buy). You can see the complete list of today’s Zacks #1 Rank stocks here.

Regeneron’s earnings per share estimates have moved north from $50.03 to $54.15 for 2021 and from $40.91 to $44.11 for 2022 in the past 30 days. The stock has risen 31.6% so far this year.


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Regeneron Pharmaceuticals, Inc. (REGN) : Free Stock Analysis Report

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Eli Lilly and Company (LLY) : Free Stock Analysis Report

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