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EU approves AstraZeneca Forxiga for use across the EU

Milestone therapy concerns the treatment of patients with symptomatic chronic heart failure

AstraZeneca’s Forxiga treatment has received approval from the EU to extend the cover to heart failure (HF) with reduced ejection fraction (HFrEF).

Consequently, it will now include patients across the full spectrum of left ventricular ejection fraction (LVEF), including HF with mildly reduced and preserved ejection fraction (HFmrEF, HFpEF).

The latest European Commission green light arrives after an initial positive opinion of the Committee for Medicinal Products for Human Use in December 2022. This had been based on positive results from the DELIVER phase 3 clinical trial.

Meanwhile, results from the research emerging from both the DELIVER and DAPA-HF phase 3 trials also confirmed Forxiga as the first HF therapy to establish mortality benefits across the full ejection fraction range.

Mene Pangalos, executive vice president, BioPharmaceuticals R&D, at AstraZeneca, was confident that the latest approval would yield positive results for patients: “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.”

HF is a chronic, long-term condition that becomes more serious over time and typically affects about 15 million people across Europe. Approximately half of HF patients die within five years of diagnosis, while patients with HFmrEF and HFpEF are at greater risk of death and hospitalisations. HFmrEF and HFpEF are also majorly under diagnosed as symptoms are often masked by other clinical conditions.

Forxiga – also known as Farxiga in the US – is approved for the treatment of patients with type 2 HFrEF, diabetes and CKD in more than 100 countries around the world including the US, EU, China and Japan. It has most recently received regulatory approvals in Britain, Japan and Turkey.

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