AstraZeneca secures Forxiga approval in China
By Josh White
Date: Thursday 04 Feb 2021
(Sharecast News) - AstraZeneca announced on Thursday that 'Forxiga', or 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.
The FTSE 100 pharmaceuticals giant described heart failure as a life-threatening chronic disease that prevented the heart from pumping sufficient levels of blood around the body.
At least half of patients with heart failure had a reduced ejection fraction, which occurs when the left ventricle muscle is not able to contract adequately, and therefore expels less oxygen-rich blood into the body.
The firm said the approval by China's National Medical Products Administration was based on positive results from the landmark 'DAPA-HF' phase 3 trial, published in the New England Journal of Medicine.
It said the National Medical Products Administration's Center for Drug Evaluation granted DAPA-HF priority review last May.
"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," said executive vice-president of biopharmaceuticals research and development Mene Pangalos.
"This approval marks another important step forward in our ambition to improve outcomes for millions of people worldwide living with this life-threatening disease."
At 0844 GMT, shares in AstraZeneca were up 1.58% at 7,415p.
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