Forxiga recommended for approval in the EU by CHMP for the treatment of patients with chronic kidney disease

If approved, Forxiga has the potential to change the treatment paradigm for millions of people in the EU suffering from chronic kidney disease

AstraZeneca’s Forxiga (dapagliflozin) has been recommended for approval in the European Union (EU) for the treatment of chronic kidney disease (CKD) in adults with and without type-2 diabetes (T2D).

The Committee for Medicinal Products for Human Use (CHMP) of the European Medicines Agency based its positive opinion on results from the DAPA-CKD Phase III trial that showed Forxiga, on top of standard-of-care treatment with an angiotensin-converting enzyme inhibitor or an angiotensin receptor blocker, reduced the risk of the composite of worsening of renal function, end-stage kidney disease (ESKD) and cardiovascular (CV) or renal death, compared to placebo.

Forxiga also significantly reduced the risk of death from any cause, compared to placebo. In the trial, the safety and tolerability of Forxiga were consistent with the well-established safety profile of the medicine.

CKD is a serious, progressive condition defined by decreased kidney function and is often associated with an increased risk of heart disease or stroke.1-3 It affects approximately 47 million people in the EU and nearly 840 million people worldwide.3,4 However, diagnosis rates remain low and up to 90% of patients are unaware they have the disease.5

Mene Pangalos, Executive Vice President, BioPharmaceuticals R&D, said: “The unprecedented results of the DAPA-CKD Phase III trial show that Forxiga can significantly slow the decline of kidney function and reduce the risk of death for patients with chronic kidney disease. This positive CHMP opinion underscores Forxiga’s potential to transform the future care of chronic kidney disease and brings us one step closer to providing a much-needed new treatment option to millions of patients in the EU.”

Forxiga (known as Farxiga in the US) was recently approved in the US for the treatment of CKD in adults with and without T2D and, in addition to the EU, is currently under review in Japan and other countries around the world. Forxiga is also indicated as an adjunct to diet and exercise to improve glycaemic control in adults with T2D and for the treatment of symptomatic chronic heart failure (HF) with reduced ejection fraction (HFrEF) in adults with and without T2D.

Tags : #LatestPharmaNewsJune28 #AstrazenecaNewsJune28 #TreatmentforChronicKidneyDisease

Related Stories

Loading Please wait...

-Advertisements-




Trending Now

The Bitter Truth Behind Sweet Treats: Hidden Cancer Risks in Your Favorite CakesOctober 03, 2024
Ageing Faster Than You Think? Discover How a Simple Cheek Swab Could Save Your LifeOctober 03, 2024
The University of Tasmania invites international student applications for their Tasmanian International ScholarshipOctober 03, 2024
A New Hope for Type 1 Diabetes: Tackling Blood Sugar Drops with Somatostatin BlockersOctober 03, 2024
Prostate Cancer Strikes Young: The Alarming Rise of Aggressive Cases in Men Under 50October 03, 2024
Fleetguard Filters Private Limited (FFPL) Wins Prestigious ‘Iconic Brands of India 2024’ at the This recognition adds to Fleetguard's growing list of accolades, further establishing its position as a leader in the automotive industry. The company remains dedicated to advancing innovation and providing solutions that consistently meet the changing needs of its customers.October 03, 2024
Mr. Piush Srivastava, Head of Marketing and Corporate Communications of Fleetguard Filters Pvt. Ltd, Awarded 'Marketing Maverick' by Dun & Bradstreet October 01, 2024
Chikungunya Strikes Back: The Forgotten Virus Making a Deadly ComebackOctober 01, 2024
The Hidden Cancer Risk in Your Morning Routine: How Poor Oral Hygiene May Be Endangering Your HealthOctober 01, 2024
Toxic Wrappings: Is Your Food Packaging Linked to Breast Cancer?September 30, 2024
My body, Is it my own?September 30, 2024
A Cure for Type 1 Diabetes? The Game-Changing Power of Stem Cell TherapySeptember 30, 2024
The Future of Health: Why Ayurveda's Inclusion in Ayushman Bharat is a MilestoneSeptember 30, 2024
Nutriwiz Launches Affordable Milk Mixes to Combat Micronutrient Deficiencies at ISF 2024September 28, 2024
World Heart Day- Tetsuya Yamada - Managing Director, OMRON Healthcare India.September 28, 2024
Amritapuri Celebrates Amma's 71st BirthdaySeptember 28, 2024
Is Poor Sleep During Pregnancy Setting Your Baby Up for Developmental Challenges?September 28, 2024
Can India Save Modern Medicine? The War Against Antimicrobial Resistance Begins HereSeptember 28, 2024
Mpox Clade I: The Deadly Virus India's Fighting to ContainSeptember 28, 2024
From Desk to Date: Quick Hair Transformations for busy ProfessionalsSeptember 27, 2024