Friday, October 15, 2021

AZ’s Farxiga scores US approval in chronic kidney disease




The US Food and Drug Administration (FDA) has approved AstraZeneca’s (AZ) oral SGLT2 inhibitor Farxiga for the treatment of chronic kidney disease (CKD) in adults at risk of progression, with and without type 2 diabetes.

The approval, which has been labelled an “important step forward in helping people living with kidney disease”, is based on results from the Phase III DAPA-CKD trial and follows a priority review designation granted by the FDA earlier this year.

In the DAPA-CKD trial, Farxiga plus standard-of-care treatment reduced the relative risk of worsening of renal function, onset of end-stage kidney disease (ESKD) or risk of cardiovascular (CV) or renal death by 39% compared to placebo in patients with stages 2-4 CKD and elevated urinary albumin excretion.

In addition, the absolute risk reduction was 5.3% over the median time in study of 2.4 years, with Farxiga also significantly reducing the relative risk of death from any cause by 31% compared to placebo.

“[This] approval is the most significant advancement in the treatment of chronic kidney disease in more than 20 years,” said Mene Pangalos, executive vice president, BioPharmaceuticals R&D at AZ.

“We’ve shown impressive efficacy for Farxiga in type-2 diabetes, heart failure with reduced ejection fraction and, most recently, chronic kidney disease and we are thrilled to be able to bring this medicine to millions of patients in the US,” he added.

Farxiga is already approved as an adjunct to diet and exercise to improve glycaemic control in adults with type 2 diabetes in the US, and also to reduce the risk of hospitalisation for heart failure in adults with type 2 diabetes and established CV disease or multiple CV risk factors.

The oral SGLT2 inhibitor is also indicated to reduce the risk of CV death and hospitalisation for heart failure in adults with heart failure with reduced ejection fraction, with and without type 2 diabetes.



Source link

Latest Articles

Widely used chemical linked to 1,00,000 US deaths per year: Study

NEW YORK: Daily exposure to phthalates, a group of chemicals used in everything from plastic containers to makeup, may lead to approximately 100,000 deaths...

Foods to Reduce Inflammation and Strengthen the Immune System

Did you know that you can greatly reduce inflammation and boost your immune system by simply incorporating more anti-inflammatory foods and beverages into your...

Personal Selling

INTRODUCTION Early sellers and traders were not held in high esteem. The Roman word for salesman meant ‘Cheater’ and...

Building Muscle on a Vegan Diet

There are a lot of  misconceptions surrounding veganism. The notion that those who practice it are lacking in protein and therefore muscles is the...

Electrodes in brain new hope for severe cases of epilepsy

Neurosurgeons at All India Institute of Medical Sciences have devised a new technique for operating on children suffering from a severe form of epilepsy...