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MarketScreener Homepage  >  Equities  >  London Stock Exchange  >  AstraZeneca PLC    AZN   GB0009895292


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AstraZeneca : Granted Fast Track Designation for Farxiga

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07/16/2020 | 08:58am EDT

By Chris Wack


AstraZeneca said Thursday it has been granted fast track designation in the U.S. for the development of Farxiga dapagliflozin to reduce the risk of hospitalization for heart failure or cardiovascular death in adults following an acute myocardial infarction or heart attack.

The company said the designation is based on a Phase III DAPA-MI trial that will explore the efficacy and safety of Farxiga in this patient population.

The DAPA-MI trial is conducted in collaboration with Uppsala Clinical Research Center and Minap in the U.K. It will explore the benefit of Farxiga in patients without type-2 diabetes following an acute MI. It is expected to begin recruiting in the fourth quarter of 2020.

In May, Farxiga was approved in the U.S. to reduce the risk of CV death and hHF in adults with HF with reduced ejection fraction with and without T2D. Farxiga is also indicated as an adjunct to diet and exercise to improve glycemic control in adults with T2D. Additionally, Farxiga is being evaluated for patients with chronic kidney disease in the Phase III DAPA-CKD trial, which was stopped early after a Data Monitoring Committee determination of overwhelming efficacy.


Write to Chris Wack at chris.wack@wsj.com


Stocks mentioned in the article
ChangeLast1st jan.
ASTRAZENECA PLC -1.71% 8558 Delayed Quote.12.29%
CKD CORPORATION -6.38% 1908 End-of-day quote.3.81%
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Financials (USD)
Sales 2020 26 712 M - -
Net income 2020 3 067 M - -
Net Debt 2020 13 578 M - -
P/E ratio 2020 51,2x
Yield 2020 2,52%
Capitalization 147 B 147 B -
EV / Sales 2020 5,99x
EV / Sales 2021 5,26x
Nbr of Employees 70 600
Free-Float 95,7%
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Pascal Soriot Chief Executive Officer & Executive Director
Leif Valdemar Johansson Non-Executive Chairman
Pam P. Cheng Executive VP-Operations & Information Technology
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Menelas N. Pangalos EVP-Biopharmaceuticals Research & Development
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