# AstraZeneca’s Forxiga approved in China for heart failure

- Link: https://www.directorstalkinterviews.com/astrazenecas-forxiga-approved-in-china-for-heart-failure/412958756
- Published: 2021-02-04T07:28:05+00:00
- Author: Amilia Stone

**[AstraZeneca plc](https://www.directorstalkinterviews.com/ftse-company/astrazeneca/azn.l)**(
[LON:AZN](https://www.directorstalkinterviews.com/ftse-company/astrazeneca/azn.l))
_Forxiga_ (dapagliflozin) has been approved in China to reduce the risk of cardiovascular
death and hospitalisation for heart failure in adults with heart failure (NYHA class
II-IV) with reduced ejection fraction.

Heart failure (HF) is a life-threatening chronic disease that prevents the heart
from pumping sufficient levels of blood around the body.^(1) At least half of patients
with HF have a reduced ejection fraction (EF),^(2) which occurs when the left ventricle
muscle is not able to contract adequately, and therefore expels less oxygen-rich
blood into the body.^(3-5)

The approval by China’s National Medical Products Administration (NMPA) is based
on positive results from the landmark DAPA-HF Phase III trial, published in The 
New England Journal of Medicine. The NMPA’s Center for Drug Evaluation granted DAPA-
HF priority review in May 2020.

> **Junbo Ge, Professor, Director and Doctoral advisor in the Department of Cardiology,
> Zhongshan Hospital, Fudan University, China, and investigator in the DAPA-HF Phase
> III trial, said:** “The mortality rate of cardiovascular disease far exceeds that
> of cancer and other diseases, making it a leading cause of death in China. The
> DAPA-HF trial enrolled Chinese patients from 30 sites. Its results and today’s
> approval will support a new standard of care for the millions of people in China
> living with heart failure.”

The DAPA-HF Phase III trial demonstrated that _Forxiga_, in addition to the standard
of care consisting of an angiotensin-converting enzyme inhibitor (ACEi) or an angiotensin
receptor blocker (ARB), reduced the risk of the composite of CV death or worsening
of HF events, including hHF versus placebo by 26%, and both components of the primary
composite endpoint contributed benefit to the overall effect.^(6) _Forxiga_ is the
first sodium-glucose co-transporter 2 (SGLT2) inhibitor to have shown this benefit.
In the DAPA-HF Phase III trial, the safety profile of _Forxiga_ was consistent with
the well-established safety profile of the medicine. During the trial, one CV death
or hHF or an urgent HF visit resulting in intravenous therapy associated with HF
could be avoided for every 21 patients treated with _Forxiga_.^(6)

_Forxiga_ (known as _Farxiga_ in the US) is approved in the US, Europe, Japan and
several other countries around the world for the treatment of adult patients with
HFrEF.

_Forxiga _is advancing knowledge of cardiorenal protection as science continues 
to identify the underlying links between the heart, kidneys and pancreas_. _DAPA-
HF is part of DapaCare, a robust clinical trial programme to assess the potential
CV and renal benefits of _Forxiga_. The programme has also explored the treatment
of patients with chronic kidney disease (CKD) in the DAPA-CKD Phase III trial, with
the full results announced in August 2020 demonstrating that _Forxiga _met all primary
and secondary endpoints, including all-cause mortality. Additionally, _Forxiga _is
currently being tested in HF patients with preserved ejection fraction (HFpEF) in
the DELIVER Phase III trial, with data readout anticipated in the second half of
2021, and in patients without type-2 diabetes (T2D) following an acute myocardial
infarction (MI) or heart attack in the DAPA-MI Phase III trial – a first of its 
kind, indication-seeking registry-based randomised controlled trial.

> **Mene Pangalos, Executive Vice President, BioPharmaceuticals R&D at AstraZeneca,
> said: **“There is no known cure for chronic heart failure except for heart transplantation,
> which is why there is an urgent need for new treatment options that can improve
> symptoms and help patients live longer. This approval marks another important 
> step forward in our ambition to improve outcomes for millions of people worldwide
> living with this life-threatening disease.”

Share on: