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AstraZeneca’s heart failure drug Farxiga scores FDA priority review

Approval in HFrEF would significantly expand drug's reach


AstraZeneca’s next-generation heart failure drug Farxiga has scored a priority review from the FDA in the US, setting it up for approval by the second quarter of 2020. 

AZ had submitted a supplemental new drug application (sNDA) for Farxiga (dapagliflozin), as a treatment to reduce the risk of cardiovascular death or the worsening of heart failure in adults with reduced ejection fraction (HFrEF), with or without type 2 diabetes.

Farxiga became the first drug in the SGLT2 inhibitor class to be approved in the US to reduce the chances of hospitalisations for heart failure in adults with type 2 diabetes and other cardiovascular risks in October last year.

That approval was based on the results of the DECLARE-TIMI 58 clinical trial, which demonstrated that Farxiga was able to reduce hospitalisations for heart failure and cardiovascular death in a broad diabetes patient population, most of whom had no cardiovascular disease at enrolment, compared with placebo.

An approval in HFrEF would be an even more significant market opportunity for the drug as it enters its last few years of patent life.

AstraZeneca’s HFrEF trial of Farxiga – named DAPA-HF – was hailed as a ‘landmark trial’ when it was presented at last year’s European Society of Cardiology congress.

Data from that trial showed that Farxiga reduced the composite of cardiovascular death or worsening of heart failure by 26% when added to standard therapy.

AZ is also running a study of Farxiga in heart failure with preserved ejection fraction (HFpEF), a hard-to-treat form of the disease that currently has no approved drug therapies, which is due to read out this year.

“Farxiga is well established in the treatment of type 2 diabetes and this priority review shows its potential to also impact millions of patients with heart failure,” said Mene Pangalos, executive vice president, Biopharmaceuticals R&D, AZ.

“If approved, Farxiga will be the first and only medicine of its kind indicated to treat patients with heart failure,” he added.

AZ is hoping to make some gains on SGLT2 inhibitor market leader Jardiance (empagliflozin) from Eli Lilly and Boehringer Ingelheim.

Boehringer and Lilly are also testing Jardiance in both HFrEF and EFpEF with two trials – EMPEROR-Reduced and EMPEROR-Preserved – which are also due to produce results this year.

Article by
Lucy Parsons

6th January 2020

From: Regulatory


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