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Lilly (LLY) Jardiance Kidney Disease sNDA Gets FDA Acceptance
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Eli Lilly and Company (LLY - Free Report) and partner Boehringer Ingelheim announced that the FDA has accepted its supplemental new drug application (sNDA) seeking approval of its SGLT-2 inhibitor Jardiance (empagliflozin) for chronic kidney disease (CKD) indication.
The sNDA, which seeks approval for Jardiance, Lilly’s blockbuster diabetes once-daily medicine, to reduce the risk of kidney disease progression and cardiovascular death in adults with CKD, was based on data from the EMPA-KIDNEY phase III study. Data from the study showed that treatment with Jardiance plus standard of care led to a 28% reduction in the risk of kidney disease progression or cardiovascular death in adults with CKD compared with placebo on top of standard of care.
The FDA had granted Fast Track designation to Jardiance to reduce the risk of kidney disease progression and cardiovascular death in adults with CKD in March 2020.
We remind investors that in March 2022, an Independent Data Monitoring Committee had recommended that the EMPA-KIDNEY study be stopped early. The recommendation followed a formal interim assessment that demonstrated a clear positive efficacy in people with chronic kidney disease
Lilly’s stock has risen 43.9% in the past year compared with an increase of 16.1% for the industry.
Image Source: Zacks Investment Research
Other than type II diabetes, Jardiance is also approved to reduce cardiovascular death in adults with type II diabetes and known cardiovascular disease. Jardiance was approved for chronic heart failure in people with reduced left ventricular ejection fraction (LVEF) and for heart failure with preserved LVEF indication in 2021/2022.
Jardiance is a key top-line driver for Lilly. In the first nine months of 2022, it generated sales worth $1.45 billion, up 37% year over year. The potential approval for the CKD indication can boost sales higher in the future quarters.
Other SGLT2 inhibitors available in the market are J&J’s (JNJ - Free Report) Invokana and AstraZeneca’s (AZN - Free Report) Farxiga/Forxiga.
AstraZeneca’s Farxiga/Forxiga recorded sales of $3.2 billion, up 49% year over year.
Farxiga/Forxiga was approved for the CKD indication in the United States and EU in 2021. AstraZeneca’s Farxiga was approved for the treatment of heart failure with reduced ejection fraction indication in the United States and EU in 2020. Late-stage studies are ongoing on Farxiga for heart failure with preserved ejection fraction (HFpEF) and myocardial infarction.
J&J’s Invokana recorded sales of $357 million, down 19.5% year over year.
A better-ranked large drugmaker is Sanofi (SNY - Free Report) , which has a Zacks Rank #2 (Buy).
Estimates for Sanofi’s 2022 earnings per share have increased from $4.16 per share to $4.31 while that for 2023 have jumped from $4.31 per share to $4.40 in the past 60 days. Sanofi’s stock has declined 3.5% in the past year.
Sanofi beat earnings expectations in all the trailing four quarters. The company delivered a four-quarter earnings surprise of 9.50%, on average.
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Lilly (LLY) Jardiance Kidney Disease sNDA Gets FDA Acceptance
Eli Lilly and Company (LLY - Free Report) and partner Boehringer Ingelheim announced that the FDA has accepted its supplemental new drug application (sNDA) seeking approval of its SGLT-2 inhibitor Jardiance (empagliflozin) for chronic kidney disease (CKD) indication.
The sNDA, which seeks approval for Jardiance, Lilly’s blockbuster diabetes once-daily medicine, to reduce the risk of kidney disease progression and cardiovascular death in adults with CKD, was based on data from the EMPA-KIDNEY phase III study. Data from the study showed that treatment with Jardiance plus standard of care led to a 28% reduction in the risk of kidney disease progression or cardiovascular death in adults with CKD compared with placebo on top of standard of care.
The FDA had granted Fast Track designation to Jardiance to reduce the risk of kidney disease progression and cardiovascular death in adults with CKD in March 2020.
We remind investors that in March 2022, an Independent Data Monitoring Committee had recommended that the EMPA-KIDNEY study be stopped early. The recommendation followed a formal interim assessment that demonstrated a clear positive efficacy in people with chronic kidney disease
Lilly’s stock has risen 43.9% in the past year compared with an increase of 16.1% for the industry.
Image Source: Zacks Investment Research
Other than type II diabetes, Jardiance is also approved to reduce cardiovascular death in adults with type II diabetes and known cardiovascular disease. Jardiance was approved for chronic heart failure in people with reduced left ventricular ejection fraction (LVEF) and for heart failure with preserved LVEF indication in 2021/2022.
Jardiance is a key top-line driver for Lilly. In the first nine months of 2022, it generated sales worth $1.45 billion, up 37% year over year. The potential approval for the CKD indication can boost sales higher in the future quarters.
Other SGLT2 inhibitors available in the market are J&J’s (JNJ - Free Report) Invokana and AstraZeneca’s (AZN - Free Report) Farxiga/Forxiga.
AstraZeneca’s Farxiga/Forxiga recorded sales of $3.2 billion, up 49% year over year.
Farxiga/Forxiga was approved for the CKD indication in the United States and EU in 2021. AstraZeneca’s Farxiga was approved for the treatment of heart failure with reduced ejection fraction indication in the United States and EU in 2020. Late-stage studies are ongoing on Farxiga for heart failure with preserved ejection fraction (HFpEF) and myocardial infarction.
J&J’s Invokana recorded sales of $357 million, down 19.5% year over year.
Zacks Rank & Stock to Consider
Eli Lilly has a Zacks Rank #4 (Sell) currently.
You can see the complete list of today’s Zacks #1 Rank (Strong Buy) stocks here.
A better-ranked large drugmaker is Sanofi (SNY - Free Report) , which has a Zacks Rank #2 (Buy).
Estimates for Sanofi’s 2022 earnings per share have increased from $4.16 per share to $4.31 while that for 2023 have jumped from $4.31 per share to $4.40 in the past 60 days. Sanofi’s stock has declined 3.5% in the past year.
Sanofi beat earnings expectations in all the trailing four quarters. The company delivered a four-quarter earnings surprise of 9.50%, on average.