Forxiga is already approved in more than 100 countries worldwide, to treat patients with type-2 diabetes (T2D), HFrEF and CKD, and the expanded approval covers the full spectrum of left ventricular ejection fraction (LVEF)
AstraZeneca has received the European Commission (EC) approval for expanded indication of Forxiga (dapagliflozin) to include heart failure (HF) with reduced ejection fraction (HFrEF).
Forxiga is an oral, once-daily SGLT2 inhibitor, with potential in preventing and delaying cardiorenal disease, while also protecting the organs.
The drug is already approved in more than 100 countries worldwide, including the US, the EU, China, and Japan, to treat patients with type-2 diabetes (T2D), HFrEF and CKD.
The expanded approval covers the full spectrum of left ventricular ejection fraction (LVEF), including HF with mildly reduced and preserved ejection fraction (HFmrEF, HFpEF).
It follows the positive opinion from the European Medicines Agency’s (EMA) Committee for Medicinal Products for Human Use, granted in December last year.
Forxiga was recently approved in the UK, Japan, and Turkey to extend the HF indication to include patients across the full spectrum of LVEF.
AstraZeneca biopharmaceuticals R&D executive vice president Mene Pangalos said: “This broader indication for Forxiga for the treatment of symptomatic chronic heart failure across the full ejection fraction range will help more patients to benefit from this well-tolerated and guideline-directed treatment.
“We are redefining treatment of cardiorenal diseases with Forxiga’s demonstration of life-saving benefits, underscoring AstraZeneca’s commitment to provide innovative solutions that can help address the complexities of heart failure across the spectrum of the disease.”
The EU regulator granted expanded approval for Forxiga based on the positive results from the Phase 3 DELIVER trial, which evaluated the efficacy of Forxiga, compared with placebo.
In the study, HF patients with LVEF received Forxiga once daily in addition to background therapy, a regional SoC for all comorbidities, including diabetes and hypertension.
The time to first occurrence of CV death, hHF or an urgent HF visit was the primary composite endpoint of the study.
The total number of HF events and CV death, change in the total symptom score from baseline, time to the occurrence of CV death and time to the occurrence of death from any cause, include the key secondary endpoints.
Furthermore, results from pooled analysis of Phase 3 DELIVER and DAPA-HF trials established Forxiga as HF medication with mortality benefit across the full ejection fraction range, said the British drugmaker.