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AstraZeneca (AZN) Farxiga Gets Priority Tag for Kidney Disease
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AstraZeneca plc (AZN - Free Report) announced that FDA has granted priority review to its regulatory application seeking approval to expand the label of its blockbuster diabetes medicine, Farxiga for the treatment of new or worsening chronic kidney disease (CKD) in adults with and without type-II diabetes (T2D). The FDA’s decision is expected in the second quarter of 2021.
Farxiga is presently approved to treat T2D and heart failure with reduced ejection fraction in the United States. If approved for CKD, Farxiga will be the first SGLT2 inhibitor approved to treat patients with CKD, with and without T2D
The regulatory application was based on positive results from the DAPA-CKD phase III study on Farxiga. Data from the study has shown that Farxiga significantly reduced the composite measure of worsening of renal function or risk of death in the study by 39% in patients with CKD Stages 2-4 and elevated urinary albumin excretion.
We remind investors that in March last year, the DAPA-CKD study was stopped early on the recommendation of an independent Data Monitoring Committee based on its determination of overwhelming efficacy.
This year so far, AstraZeneca’s shares have declined 0.9% against an increase of 4% for the industry.
Several outcomes studies are ongoing on Farxiga for heart failure indications and CKD indications under the DapaCare clinical program, which includes more than 35 completed and ongoing phase IIb/III studies. DAPA-CKD is part of the DapaCare program. Farxiga is being studied in the DELIVER study to evaluate its effect on patients with heart failure (HF) with preserved ejection fraction (HFpEF). DAPA-MI study is evaluating patients without T2D following an acute myocardial infarction (MI) or heart attack.
Farxiga/Forxiga (Farxiga’s name in outside U.S. market), a key top-line driver of AstraZeneca, generated sales worth $1.38 billion in the first nine months of 2020, representing 26% growth at constant exchange rates. Farxiga enjoys global leadership with a significant market share.
Other SGLT2 inhibitors available in the market are Johnson & Johnson’s (JNJ - Free Report) Invokana and Lilly’s (LLY - Free Report) and Boehringer Ingelheim's, Jardiance. Another successful diabetes medicine, which is not a SGLT2 drug, is Novo Nordisk’s (NVO - Free Report) GLP-1 drug, Victoza.
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AstraZeneca (AZN) Farxiga Gets Priority Tag for Kidney Disease
AstraZeneca plc (AZN - Free Report) announced that FDA has granted priority review to its regulatory application seeking approval to expand the label of its blockbuster diabetes medicine, Farxiga for the treatment of new or worsening chronic kidney disease (CKD) in adults with and without type-II diabetes (T2D). The FDA’s decision is expected in the second quarter of 2021.
Farxiga is presently approved to treat T2D and heart failure with reduced ejection fraction in the United States. If approved for CKD, Farxiga will be the first SGLT2 inhibitor approved to treat patients with CKD, with and without T2D
The regulatory application was based on positive results from the DAPA-CKD phase III study on Farxiga. Data from the study has shown that Farxiga significantly reduced the composite measure of worsening of renal function or risk of death in the study by 39% in patients with CKD Stages 2-4 and elevated urinary albumin excretion.
We remind investors that in March last year, the DAPA-CKD study was stopped early on the recommendation of an independent Data Monitoring Committee based on its determination of overwhelming efficacy.
This year so far, AstraZeneca’s shares have declined 0.9% against an increase of 4% for the industry.
Several outcomes studies are ongoing on Farxiga for heart failure indications and CKD indications under the DapaCare clinical program, which includes more than 35 completed and ongoing phase IIb/III studies. DAPA-CKD is part of the DapaCare program. Farxiga is being studied in the DELIVER study to evaluate its effect on patients with heart failure (HF) with preserved ejection fraction (HFpEF). DAPA-MI study is evaluating patients without T2D following an acute myocardial infarction (MI) or heart attack.
Farxiga/Forxiga (Farxiga’s name in outside U.S. market), a key top-line driver of AstraZeneca, generated sales worth $1.38 billion in the first nine months of 2020, representing 26% growth at constant exchange rates. Farxiga enjoys global leadership with a significant market share.
Other SGLT2 inhibitors available in the market are Johnson & Johnson’s (JNJ - Free Report) Invokana and Lilly’s (LLY - Free Report) and Boehringer Ingelheim's, Jardiance. Another successful diabetes medicine, which is not a SGLT2 drug, is Novo Nordisk’s (NVO - Free Report) GLP-1 drug, Victoza.
AstraZeneca currently carries a Zacks Rank #3 (Hold). You can see the complete list of today’s Zacks #1 Rank (Strong Buy) stocks here.
Breakout Biotech Stocks with Triple-Digit Profit Potential
The biotech sector is projected to surge beyond $775 billion by 2024 as scientists develop treatments for thousands of diseases. They’re also finding ways to edit the human genome to literally erase our vulnerability to these diseases.
Zacks has just released Century of Biology: 7 Biotech Stocks to Buy Right Now to help investors profit from 7 stocks poised for outperformance. Our recent biotech recommendations have produced gains of +50%, +83% and +164% in as little as 2 months. The stocks in this report could perform even better.
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