Forxiga is claimed to be the first approved SGLT2 inhibitor for chronic heart failure with reduced ejection fraction in Japanese T2D patients
New Cambridge R&D Centre and Global Headquarters - Aerial view. (Credit: AstraZeneca.)
AstraZeneca received Japanese regulatory approval for Forxiga (dapagliflozin) to treat patients with chronic heart failure (HF) who are receiving standard of care.
HF is a chronic heart disease, caused when the left ventricle muscle fails to contract properly, resulting in less oxygen-rich blood pumped by the heart into the body parts.
Forxiga is a first-in-class, oral, once-daily sodium-glucose co-transporter 2 (SGLT2) inhibitor, shown to reduce the risk of the composite of cardiovascular (CV) death or worsening of HF events, including hospitalisation for HF (hHF).
The drug is currently being studied in Phase 3 trials DELIVER (HF with preserved ejection fraction, HFpEF) in patients with HF, and DETERMINE (HFrEF and HFpEF).
In 2013, AstraZeneca’s Japanese subsidiary AstraZeneca K.K. (AZKK) has reached an agreement with Ono Pharmaceutical, for Forxiga.
Under the terms of the agreement, Ono will undertake the distribution and marketing of Forxiga tablets in Japan and co-promote the drug along with AZKK.
The drug is currently approved in the US, Europe, and several other countries, for the treatment of patients with HF with reduced ejection fraction (HFrEF).
AstraZeneca BioPharmaceuticals R&D executive vice president Mene Pangalos said: “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.
“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.”
The Japanese Ministry of Health, Labour and Welfare (MHLW) has approved Forxiga based on positive results from the Phase 3 Dapagliflozin And Prevention of Adverse-outcomes in Heart Failure (DAPA-HF) trial.
DAPA-HF is part of DapaCare, a clinical trial programme to evaluate the potential CV and renal benefits of Forxiga. The programme also studied the treatment of patients with chronic kidney disease (CKD) in the Phase 3 DAPA-CKD trial.
In the Phase 3 trial, treatment using Forxiga plus standard of care demonstrated 26% reduction in the risk of the composite outcome, compared to placebo. Both components of the primary composite endpoint contributed benefit to the overall effect, said the company.
Also, Forxiga showed a consistent safety profile in the Phase 3 DAPA-HF trial, with the previously established safety profile of the drug.
Phase 3 DAPA-HF trial investigator Masafumi Kitakaze said: “Heart failure is a condition affecting 1.3 million people in Japan. Many patients have considerably reduced heart function, such as left ventricular reduced ejection fraction.
“Approximately half of patients will die within five years of diagnosis, which is worse than some cancers. With no known cure except for heart transplant, a new effective treatment option on top of the current standard of care may offer hope for people struggling with this disease and a new tool for cardiologists.”