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AstraZeneca (AZN) Forxiga Approved in Japan for Heart Failure

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AstraZeneca plc (AZN - Free Report) announced that Japan’sMinistry of Health, Labour and Welfare (MHLW) has granted approval to expand the label of Forxiga for the treatment of chronic heart failure with reduced ejection fraction (HFrEF) in adults with and without type-II diabetes (T2D). The sNDA was based on positive results from the DAPA-HF phase III study on Farxiga.

Data from the DAPA-HF study showed that Forxiga, in addition to standard of care, reduced the risk of the composite outcome versus placebo by 26%.

Forxiga was approved in EU fora similar label expansion last month and in the United States in May 2020.

This year so far, AstraZeneca’s shares have risen 9.4% compared with an increase of 4.9% for the industry.

 

Several outcomes studies are ongoing on Farxiga for heart failure indications and chronic kidney disease (CKD) indications under the DapaCare clinical program. DAPA-HF is part of the DapaCare program. Farxiga (Forxiga’s name in United States) 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.  DAPA-CKD has been conducted in patients with CKD.

Farxiga/Forxiga, a key top-line driver of AstraZeneca, generated sales worth $1.38 billion in the 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.

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