AstraZeneca: FDA Grants Fast Track Designation for Farxiga in Heart Failure
16 Setembro 2019 - 9:24AM
Dow Jones News
By Michael Dabaie
AstraZeneca PLC (AZN) said the U.S. Food and Drug Administration
granted fast track designation for Farxiga in heart failure.
The company said it was granted the designation for the
development of Farxiga to reduce the risk of cardiovascular death
or the worsening of heart failure in adults with heart failure with
reduced ejection fraction or preserved ejection fraction.
The FDA's fast track program is designed to accelerate the
development and review of new medicines for the treatment of
serious conditions where there is an unmet treatment need.
The drug is currently approved as a monotherapy and as part of
combination therapy to improve glycemic control in adults with type
2 diabetes. In August, the FDA granted fast track approval for the
development of Farxiga to delay the progression of renal failure
and prevent cardiovascular and renal death in patients with chronic
kidney disease.
Write to Michael Dabaie at michael.dabaie@wsj.com
(END) Dow Jones Newswires
September 16, 2019 08:09 ET (12:09 GMT)
Copyright (c) 2019 Dow Jones & Company, Inc.
Astrazeneca (LSE:AZN)
Gráfico Histórico do Ativo
De Nov 2024 até Dez 2024
Astrazeneca (LSE:AZN)
Gráfico Histórico do Ativo
De Dez 2023 até Dez 2024
