Sunday, June 22, 2025
Distribution: (800) 510 0384
Washington DC
New York
Toronto
Press ID  
  • Login
The Hudson Weekly
  • Financial
  • Blockchain
  • Technology
  • Entertainment
  • Lifestyle
  • Arts
  • Health
  • Sports
  • Cybersecurity
No Result
View All Result
  • Financial
  • Blockchain
  • Technology
  • Entertainment
  • Lifestyle
  • Arts
  • Health
  • Sports
  • Cybersecurity
No Result
View All Result
The Hudson Weekly
No Result
View All Result

FDA Approves Treatment for Chronic Kidney Disease

Approval is First to Cover Many Causes of Disease

Craig Richer by Craig Richer
May 3, 2021
in Health
A A
FDA Accepts BioMarin’s New Drug Application for Vosoritide to Treat Children with Achondroplasia

© FDA

Share on FacebookShare on Twitter

U.S. Food and Drug Administration approved Farxiga (dapagliflozin) oral tablets to reduce the risk of kidney function decline, kidney failure, cardiovascular death and hospitalization for heart failure in adults with chronic kidney disease who are at risk of disease progression.

“Chronic kidney disease is an important public health issue, and there is a significant unmet need for therapies that slow disease progression and improve outcomes,” said Aliza Thompson, M.D., M.S., deputy director of the Division of Cardiology and Nephrology in the FDA’s Center for Drug Evaluation and Research. “Today’s approval of Farxiga for the treatment of chronic kidney disease is an important step forward in helping people living with kidney disease.”

HudsonNewsroom

Prioritizing Your Mental Health When Going Through Divorce

Chemistry Meets Cannabis: The Science Behind THCA vs. THC

Elevating Daily Hygiene: The Rise of Organic Feminine Wipes

Chronic kidney disease occurs when the kidneys are damaged and cannot filter blood normally. Due to this defective filtering, patients can have complications related to fluid, electrolytes (minerals required for many bodily processes), and waste build-up in the body. Chronic kidney disease sometimes can progress to kidney failure. Patients also are at high risk of cardiovascular disease, including heart disease and stroke.

The efficacy of Farxiga to improve kidney outcomes and reduce cardiovascular death in patients with chronic kidney disease was evaluated in a multicenter, double-blind study. In this study, 4,304 patients were randomly assigned to receive either Farxiga or a placebo. The study compared the two groups for the number of patients whose disease progressed to a composite (or combined) endpoint that included at least a 50% reduction in kidney function, progression to kidney failure, or cardiovascular or kidney death. Results showed that 197 of the 2,152 patients who received Farxiga had at least one of the composite endpoint events compared to 312 of the 2,152 patients who received a placebo. The study also compared the two groups for the number of patients who were hospitalized for heart failure or died from cardiovascular disease. A total of 100 patients who received Farxiga were hospitalized or died compared to 138 patients who received a placebo.

Farxiga was not studied, nor is expected to be effective, in treating chronic kidney disease among patients with autosomal dominant or recessive polycystic (characterized by multiple cysts) kidney disease or among patients who require or have recently used immunosuppressive therapy to treat kidney disease.

Patients should not use Farxiga if they have a history of serious hypersensitivity reactions to the medication or if they are on dialysis treatment. Serious, life-threatening cases of Fournier’s Gangrene have occurred in patients with diabetes taking Farxiga. Patients should consider a lower dose of insulin or insulin secretagogue to reduce the risk of hypoglycemia (low blood sugar) if they are also taking Farxiga. Farxiga can cause dehydration, serious urinary tract infections, genital yeast infections, and metabolic acidosis or ketoacidosis (acid build-up in the blood). Patients should be assessed for their volume status and kidney function before starting Farxiga.

Farxiga was originally approved in 2014 to improve glycemic control in adults with type 2 diabetes in addition to diet and exercise.

Farxiga received Fast Track, Breakthrough Therapy, and Priority Review designations for the indication being approved today. Fast track is designed to facilitate the development and expedite the review of drugs to treat serious conditions and fill an unmet medical need. Breakthrough therapy designation is designed to expedite the development and review of drugs that are intended to treat a serious condition and preliminary clinical evidence indicates that the drug may demonstrate substantial improvement over available therapy on a clinically significant endpoint(s). Priority review directs overall attention and resources to the evaluation of applications for drugs that, if approved, would be significant improvements in the safety or effectiveness of the treatment, diagnosis or prevention of serious conditions when compared to standard applications.

The FDA granted the approval of Farxiga to AstraZeneca.

Craig Richer

Craig Richer

Newsroom Editor

More from HW Newsdesk

Prioritizing Your Mental Health When Going Through Divorce
Health

Prioritizing Your Mental Health When Going Through Divorce

June 21, 2025
Chemistry Meets Cannabis: The Science Behind THCA vs. THC
Health

Chemistry Meets Cannabis: The Science Behind THCA vs. THC

June 21, 2025
Elevating Daily Hygiene: The Rise of Organic Feminine Wipes
Health

Elevating Daily Hygiene: The Rise of Organic Feminine Wipes

June 18, 2025

HW Newsroom

The How-To Guide for Efficiently Managing Grants
Financial

The How-To Guide for Efficiently Managing Grants

by Hayley Chowdhry
June 21, 2025

Managing grants efficiently involves a careful strategy that focuses on planning, execution, and ongoing communication. Nonprofits, educational institutions, and research...

Top Advantages of Implementing Centralized Log Management

Top Advantages of Implementing Centralized Log Management

June 21, 2025
Before You Dig: Key Requirements for Excavation Projects

Before You Dig: Key Requirements for Excavation Projects

June 21, 2025
Reasons Why Real Estate Marketing is Crucial for Agents

Reasons Why Real Estate Marketing is Crucial for Agents

June 21, 2025
How to Handle Tough Questions Like a Pro During Presentations

How to Handle Tough Questions Like a Pro During Presentations

June 21, 2025
Exploring the Role of Betting in Today’s Sports Culture

Exploring the Role of Betting in Today’s Sports Culture

June 21, 2025
The Best Destinations for Solo Travelers Looking to Meet New People

The Best Destinations for Solo Travelers Looking to Meet New People

June 21, 2025
How Early Adopters of Specialized AI Are Winning New Business

Remote Desktop Software for Mac: Top Picks for Enhanced Performance

June 21, 2025
How to Choose the Right Lead Generation Agency for B2B Growth in 2025

How to Choose the Right Lead Generation Agency for B2B Growth in 2025

June 21, 2025
Launching AI-Powered ICO: Why Early Investors Are Paying Attention

Launching AI-Powered ICO: Why Early Investors Are Paying Attention

June 21, 2025
How to Use a Self-Directed IRA to Invest in What You Actually Understand

How to Use a Self-Directed IRA to Invest in What You Actually Understand

June 21, 2025
Chemistry Meets Cannabis: The Science Behind THCA vs. THC

Chemistry Meets Cannabis: The Science Behind THCA vs. THC

June 21, 2025
No Result
View All Result

Headlines

7 Key Considerations When Looking for a Crypto Wallet

The Case for (and Against) Front License Plates

Credit Score Check Tools: Free vs. Paid Options Explained

The How-To Guide for Efficiently Managing Grants

Top Advantages of Implementing Centralized Log Management

Before You Dig: Key Requirements for Excavation Projects

Trending

From Budget to Shingles: A Step-by-Step Guide to Roof Planning
Lifestyle

From Budget to Shingles: A Step-by-Step Guide to Roof Planning

by Dennis Keller
June 21, 2025

Replacing or installing a new roof is one of the most important investments a homeowner can make....

Prioritizing Your Mental Health When Going Through Divorce

Prioritizing Your Mental Health When Going Through Divorce

June 21, 2025
7 Key Considerations When Looking for a Crypto Wallet

7 Key Considerations When Looking for a Crypto Wallet

June 21, 2025
The Case for (and Against) Front License Plates

The Case for (and Against) Front License Plates

June 21, 2025
Do Payday Loans Affect Your Credit Score

Credit Score Check Tools: Free vs. Paid Options Explained

June 21, 2025
  • Kia America представляет цены и захватывающие обновления для Sorento 2025 (ICE)

https://madisongraph.com/kia-america-unveils-pricing-and-exciting-updates-for-2025-sorento-ice/

#nyc #losangeles #chicago #houston #phoenix #philadelphia #sandiego #dallas #sanfrancisco #seattle #denver #washingtondc #boston #detroit #vancouver #toronto #publicrelations #marketingagency #earnedmedia #editorial #marketing #guestpost #guestposting #sponsored #sponsoredpost
  • Kia Recognized as One of TIME Magazine’s “World’s Most Sustainable Companies of 2024”

https://madisongraph.com/kia-recognized-as-one-of-time-magazines-worlds-most-sustainable-companies-of-2024/

#nyc #losangeles #chicago #houston #phoenix #philadelphia #sandiego #dallas #sanfrancisco #seattle #denver #washingtondc #boston #detroit #vancouver #toronto #publicrelations #marketingagency #earnedmedia #editorial #marketing #guestpost #guestposting #sponsored #sponsoredpost
  • VinFast Auto Establishes Dealer Advisory Board to Enhance Customer Experience

https://madisongraph.com/vinfast-auto-establishes-dealer-advisory-board-to-enhance-customer-experience/

#nyc #losangeles #chicago #houston #phoenix #philadelphia #sandiego #dallas #sanfrancisco #seattle #denver #washingtondc #boston #detroit #vancouver #toronto #publicrelations #marketingagency #earnedmedia #editorial #marketing #guestpost #guestposting #sponsored #sponsoredpost
  • Medicare Announces Expansion of Coverage for Microprocessor-Controlled Knees for Lower Mobility Users

https://lincolncitizen.com/medicare-announces-expansion-of-coverage-for-microprocessor-controlled-knees-for-lower-mobility-users/

#nyc #losangeles #chicago #houston #phoenix #philadelphia #sandiego #dallas #sanfrancisco #seattle #denver #washingtondc #boston #detroit #vancouver #toronto #publicrelations #marketingagency #earnedmedia #editorial #marketing #guestpost #guestposting #sponsored #sponsoredpost
  • GA-ASI Successfully Tests PT6 Engine on MQ-9B SkyGuardian Aircraft

https://lincolncitizen.com/ga-asi-successfully-tests-pt6-engine-on-mq-9b-skyguardian-aircraft/

#nyc #losangeles #chicago #houston #phoenix #philadelphia #sandiego #dallas #sanfrancisco #seattle #denver #washingtondc #boston #detroit #vancouver #toronto #publicrelations #marketingagency #earnedmedia #editorial #marketing #guestpost #guestposting #sponsored #sponsoredpost
  • U.S. Leading Economic Index Declines by 0.2% in June 2024, Coincident Index Rises by 0.3%

https://fairmontpost.com/u-s-leading-economic-index-declines-by-0-2-in-june-2024-coincident-index-rises-by-0-3/

#nyc #losangeles #chicago #houston #phoenix #philadelphia #sandiego #dallas #sanfrancisco #seattle #denver #washingtondc #boston #detroit #vancouver #toronto #publicrelations #marketingagency #earnedmedia #editorial #marketing #guestpost #guestposting #sponsored #sponsoredpost
  • USTDA Director Travels to Bulgaria and Romania to Promote Clean, Secure Energy

https://belmontstar.com/ustda-director-travels-to-bulgaria-and-romania-to-promote-clean-secure-energy/

#nyc #losangeles #chicago #houston #phoenix #philadelphia #sandiego #dallas #sanfrancisco #seattle #denver #washingtondc #boston #detroit #vancouver #toronto #publicrelations #marketingagency #earnedmedia #editorial #marketing #guestpost #guestposting #sponsored #sponsoredpost
  • Police Recommend a Hidden Camera Detector Device to Protect Privacy

https://marketsherald.com/police-recommend-a-hidden-camera-detector-device-to-protect-privacy/

#nyc #losangeles #chicago #houston #phoenix #philadelphia #sandiego #dallas #sanfrancisco #seattle #denver #washingtondc #boston #detroit #vancouver #toronto #publicrelations #marketingagency #earnedmedia #editorial #marketing #guestpost #guestposting #sponsored #sponsoredpost

© 2025 The Hudson Weekly. Published by The Ritz Herald. Editions: Markets Herald • Lincoln Citizen • Madison Graph • Belmont Star • Fairmont Post

Address: 1177 6th Avenue, 5th Floor, New York, NY 10036. Removals: pr@hudsonweekly.com. Phone: (718) 313-5252. M-F: 9AM-5PM. Privacy Policy

Welcome Back!

Login to your account below

Forgotten Password?

Retrieve your password

Please enter your username or email address to reset your password.

Log In

Add New Playlist

No Result
View All Result
  • Financial
  • Blockchain
  • Technology
  • Entertainment
  • Lifestyle
  • Arts
  • Health
  • Sports
  • Cybersecurity

© 2025. The Hudson Weekly