Eli Lilly and Company (LLY Quick QuoteLLY ) along with partner Boehringer Ingelheim announced that the FDA has granted a Breakthrough Therapy designation to their SGLT-2 inhibitor Jardiance (empagliflozin) for the treatment of adult patients with heart failure with preserved ejection fraction (HFpEF).
A Breakthrough Therapy status is granted to medicines being evaluated for serious conditions where early clinical evidence indicates the said medicines’ potential for substantial improvement over available therapies.
The Breakthrough Therapy tag was based on data from the EMPEROR-Preserved phase III study, which evaluated Jardiance in adults with HFpEF.
In July 2021, Lilly announced that its EMPEROR-Preserved phase III study 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.
Per management, this is the first time that any medicine-improved outcome in a study for HFpEF, which is the most challenging form of heart failure to treat. Regulatory submissions for the HFpEF indication are expected to be filed later this year.
Shares of Lilly have rallied 42.1% so far this year compared with the industry’s increase of 13.2%.
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Last month, the FDA granted an approval to Jardiance for reducing the risk of cardiovascular death plus hospitalization for another form of heart failure in adults, which is a 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.
If approved for both HFrEF and HFpEF indications in the United States, Jardiance will become the first SGLT2 inhibitor to treat the full spectrum of heart failure patients regardless of ejection fraction.
We note that Jardiance is a key top-line driver for Lilly. In the first six months of 2021, it generated sales worth $668.5 million, up 26.2% year over year. The approval for the HFrEF indication and a potential nod to the HFpEF indication can boost sales higher in the future quarters.
Jardiance is also approved to reduce cardiovascular death in adults with type II diabetes and cardiovascular disease. A phase III study on Jardiance for chronic kidney disease is ongoing.
Other SGLT2 inhibitors available in the market are J&J’s (JNJ Quick QuoteJNJ ) Invokana and AstraZeneca’s (AZN Quick QuoteAZN ) Farxiga/Forxiga.
Zacks Rank & Key Pick
Lilly currently carries a Zacks Rank #3 (Hold). A better-ranked stock in the biotech sector is Regeneron Pharmaceuticals, Inc. (REGN Quick QuoteREGN ) , which sports a Zacks Rank #1 (Strong Buy) at present. You can see the complete list of today’s Zacks #1 Rank stocks here.
Regeneron’s earnings estimates have been revised 9.3% upward for 2021 and 6.7% for 2022 over the past 60 days. The stock has surged 33.8% year to date.