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(Sharecast News) - AstraZeneca announced on Monday that 'Forxiga', or dapagliflozin, has been approved in Japan for the treatment of patients with chronic heart failure, who are receiving standard-of-care.
The FTSE 100 pharmaceuticals giant described heart failure as a life-threatening chronic disease that prevents the heart from pumping sufficient levels of blood around the body.
It affects around 64 million people worldwide, at least half of which had a reduced ejection fraction.
That occurs when the left ventricle muscle is not able to contract adequately, and thus expels less oxygen-rich blood into the body.
The approval by the Japanese Ministry of Health, Labour and Welfare (MHLW) was based on positive results from the landmark 'DAPA-HF' phase 3 trial, published in the New England Journal of Medicine.
"Forxiga's efficacy in reducing the risk of cardiovascular death or worsening of heart failure events could result in life-saving benefits for many heart failure patients in Japan," said executive vice-president of biopharmaceuticals research and development Mene Pangalos.
"Today's approval will shift the way we manage the disease by providing a treatment option that is urgently needed to improve outcomes and symptoms for these patients."
AstraZeneca described Forxiga as the first sodium-glucose co-transporter 2 (SGLT2) inhibitor to have shown a statistically significant reduction in the risk of the composite of cardiovascular death or worsening of heart failure events, including hospitalisation for heart failure.
The DAPA-HF phase 3 trial demonstrated that Forxiga, in addition to standard of care, reduced the risk of the composite outcome versus placebo by 26%, with both components of the primary composite endpoint contributing to the overall effect.
In the trial, the safety profile of Forxiga was consistent with the established safety profile of the medicine.
During the trial, one cardiovascular death or hospitalisation for heart failure, or an urgent visit resulting in intravenous therapy associated with heart failure, could be avoided for every 21 patients treated.
Forxiga, known as 'Farxiga' in the United States, is approved in the US, Europe, and several other countries, for the treatment of patients with heart failure with reduced ejection fraction.
AstraZeneca said Forxiga was advancing cardiorenal prevention as science continued to identify the underlying links between the heart, kidneys and pancreas.
DAPA-HF was part of 'DapaCare', which it described as a "robust" clinical trial programme to assess the potential cardiovascular and renal benefits of Forxiga.
The programme also explored the treatment of patients with chronic kidney disease in the ground-breaking 'DAPA-CKD' phase 3 trial.
Additionally, it was currently being tested for heart failure patients with preserved ejection fraction in the 'DELIVER' phase 3 trial, with data readout anticipated in the second half of 2021.
In 2013, the company's Japan subsidiary AstraZeneca KK entered into an agreement with Ono Pharmaceutical for Forxiga.
Based on the agreement, Ono was responsible for distribution and marketing of Forxiga tablets in Japan, and had been co-promoting it with AstraZeneca KK for the treatment of type-2 and type-1 diabetes.
Both companies would co-promote it for the treatment of chronic heart failure.
At 0824 GMT, shares in AstraZeneca were up 1.98% at 7,924p.
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