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FDA Expands Lilly (LLY) Jardiance Label in Chronic Kidney Disease

Eli Lilly LLY announced that the FDA has expanded the label of its diabetes drug, Jardiance (empagliflozin), to chronic kidney disease (“CKD”).

Jardiance is now approved in the United States to reduce the risk of further worsening of kidney disease, end-stage kidney disease (“ESKD”), death due to cardiovascular disease, and hospitalization in adults with CKD.

The approval is based on data from the phase III EMPA-KIDNEY study, which evaluated Jardiance in adult patients with CKD. Data from the study showed that patients treated with Jardiance showed a 28% relative risk reduction over placebo, on top of standard care, for the composite primary endpoint of kidney disease progression or cardiovascular death.

Per Lilly, the EMPA-KIDNEY study is the first study on an SGLT2 inhibitor like Jardiance to demonstrate a statistically significant reduction in the risk of first and recurrent hospitalization in adults with CKD.

Following the label expansion, Jardiance is now approved for four indications in the United States. The drug is already approved for use in certain patients with heart failure and type 2 diabetes (“T2D”).

A blockbuster drug, Jardiance is one of the key revenue drivers for Lilly. During the first half of 2023, sales of Jardiance were up 42% year over at $1.25 billion, driven by the drug’s increased demand.

Shares of Eli Lilly have increased 50.5% so far this year against the industry’s 2.5% fall.

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In July, Jardiance received label expansion in the European Union (“EU”) for a similar indication based on data from the EMPA-KIDNEY study. The EU also approved the drug for heart failure and T2D indications.

Lilly has developed Jardiance in collaboration with Boehringer Ingelheim. This partnership was announced between the two companies in 2011. The companies share the ongoing development and commercialization costs per the agreement terms. Lilly receives a royalty on net product sales of Jardiance from Boehringer Ingelheim.

Per management, the latest approval significantly expands Jardiance’s market opportunities. Lilly estimates that CKD affects more than one out of seven adults in the country, representing a target market of more than 35 million adults suffering from the disease.

The Eli Lilly drug will likely provide stiff competition to AstraZeneca AZN, which markets its own SGLT2 inhibitor Farxiga (dapagliflozin), for a similar indication. AstraZeneca received the FDA approval for this indication in April 2021. The AstraZeneca drug is also approved for other indications, some of which directly compete with Jardiance. In first-half 2023, AstraZeneca recorded $2.8 billion from Farxiga sales, a 39% rise over the year-ago period.

Zacks Rank & Stocks to Consider

Eli Lilly currently carries a Zacks Rank #3 (Hold).A couple of better-ranked stocks are Annovis Bio ANVS and Novartis NVS, each carrying a Zacks Rank #2 (Buy). You can see the complete list of today’s Zacks #1 Rank (Strong Buy) stocks here.

In the past 60 days, estimates for Annovis Bio’s 2023 loss per share have narrowed from $4.89 to $4.38. During the same period, the loss estimates per share for 2024 have improved from $3.18 to $2.77. Year to date, shares of Annovis have lost 26.4%.

Earnings of Annovis Bio beat estimates in three of the last four quarters while missing the mark on one occasion, witnessing an earnings surprise of 13.40% on average. In the last reported quarter, Annovis’ earnings beat estimates by 6.14%.

In the past 30 days, estimates for Novartis’ 2023 earnings per share have risen from $6.81 to $6.92. During the same period, the estimates per share for 2024 increased from $7.32 to $7.52. Year to date, shares of Novartis have risen 11.5%.

Earnings of Novartis beat estimates in each of the trailing four quarters, witnessing an average earnings surprise of 6.56%. In the last reported quarter, Novartis’ earnings beat estimates by 8.93%.

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