The Rheumatologist
COVID-19 News
  • Connect with us:
  • Facebook
  • Twitter
  • LinkedIn
  • YouTube
  • Feed
  • Home
  • Conditions
    • Rheumatoid Arthritis
    • SLE (Lupus)
    • Crystal Arthritis
      • Gout Resource Center
    • Spondyloarthritis
    • Osteoarthritis
    • Soft Tissue Pain
    • Scleroderma
    • Vasculitis
    • Systemic Inflammatory Syndromes
    • Guidelines
  • Resource Centers
    • Axial Spondyloarthritis Resource Center
    • Gout Resource Center
    • Psoriatic Arthritis Resource Center
    • Rheumatoid Arthritis Resource Center
    • Systemic Lupus Erythematosus Resource Center
  • Drug Updates
    • Biologics & Biosimilars
    • DMARDs & Immunosuppressives
    • Topical Drugs
    • Analgesics
    • Safety
    • Pharma Co. News
  • Professional Topics
    • Ethics
    • Legal
    • Legislation & Advocacy
    • Career Development
      • Certification
      • Education & Training
    • Awards
    • Profiles
    • President’s Perspective
    • Rheuminations
    • Interprofessional Perspective
  • Practice Management
    • Billing/Coding
    • Quality Assurance/Improvement
    • Workforce
    • Facility
    • Patient Perspective
    • Electronic Health Records
    • Apps
    • Information Technology
    • From the College
    • Multimedia
      • Audio
      • Video
  • Resources
    • Issue Archives
    • ACR Convergence
      • Systemic Lupus Erythematosus Resource Center
      • Rheumatoid Arthritis Resource Center
      • Gout Resource Center
      • Abstracts
      • Meeting Reports
      • ACR Convergence Home
    • American College of Rheumatology
    • ACR ExamRheum
    • Research Reviews
    • ACR Journals
      • Arthritis & Rheumatology
      • Arthritis Care & Research
      • ACR Open Rheumatology
    • Rheumatology Image Library
    • Treatment Guidelines
    • Rheumatology Research Foundation
    • Events
  • About Us
    • Mission/Vision
    • Meet the Authors
    • Meet the Editors
    • Contribute to The Rheumatologist
    • Subscription
    • Contact
  • Advertise
  • Search
You are here: Home / Articles / FDA Approves Duzallo for Hyperuricemia in Patients with Uncontrolled Gout

FDA Approves Duzallo for Hyperuricemia in Patients with Uncontrolled Gout

August 21, 2017 • By Reuters Staff

  • Tweet
  • Email
Print-Friendly Version / Save PDF

(Reuters)—Ironwood Pharmaceuticals Inc. said on Monday the U.S. Food and Drug Administration (FDA) approved its oral drug to treat a condition associated with gout.

You Might Also Like
  • FDA Approves Lesinurad + Allopurinol
  • FDA Issues Boxed Warning for Febuxostat & Approves Colchicine for Gout Flare
  • FDA Reviewers Question Safety of AstraZeneca’s Gout Drug

The company’s once-daily drug, Duzallo (lesinurad and allopurinol), was approved to treat hyperuricemia in patients with gout, Ironwood said.

ad goes here:advert-1
ADVERTISEMENT
SCROLL TO CONTINUE

Duzallo combines the standard-of-care treatment, allopurinol, with Ironwood’s lesinurad to treat inefficient excretion and overproduction of uric acid in gout patients.

Duzallo’s label comes with a black box warning regarding the risk of acute renal failure, the company said.

ad goes here:advert-2
ADVERTISEMENT
SCROLL TO CONTINUE

The warning is a result of the risk of acute renal failure associated with lesinurad, which was also approved with a boxed warning, Ironwood said in an emailed statement.

Last year, Ironwood bought the U.S. marketing rights for lesinurad from AstraZeneca Plc. for an upfront payment of $100 million.

Gout affects about 4% of Americans, according to the U.S. Centers for Disease Control and Prevention.

ad goes here:advert-3
ADVERTISEMENT
SCROLL TO CONTINUE

Ironwood expects its portfolio of gout drugs to generate more than $300 million in annual U.S. peak sales, said Tom McCourt, the company’s chief commercial officer. Shares of the Cambridge, Ma.-based company were up 6.9% at $15.50 in premarket trading.

Filed Under: Conditions, Crystal Arthritis, Drug Updates Tagged With: Allopurinol, FDA, Food and Drug Administration, Gout, Ironwood Pharmaceuticals Inc., lesinurad

You Might Also Like:
  • FDA Approves Lesinurad + Allopurinol
  • FDA Issues Boxed Warning for Febuxostat & Approves Colchicine for Gout Flare
  • FDA Reviewers Question Safety of AstraZeneca’s Gout Drug
  • Piclidenoson in Trials for Psoriasis & RA; Plus Duzallo Approved in Europe

American College of Rheumatology

Visit the official website for the American College of Rheumatology.

Visit the ACR »

Meeting Abstracts

Browse and search abstracts from the ACR Convergence and ACR/ARP Annual Meetings going back to 2012.

Visit the Abstracts site »

Rheumatology Research Foundation

The Foundation is the largest private funding source for rheumatology research and training in the U.S.

Learn more »

The Rheumatologist newsmagazine reports on issues and trends in the management and treatment of rheumatic diseases. The Rheumatologist reaches 11,500 rheumatologists, internists, orthopedic surgeons, nurse practitioners, physician assistants, nurses, and other healthcare professionals who practice, research, or teach in the field of rheumatology.

About Us / Contact Us / Advertise / Privacy Policy / Terms of Use

  • Connect with us:
  • Facebook
  • Twitter
  • LinkedIn
  • YouTube
  • Feed

Copyright © 2006–2022 American College of Rheumatology. All rights reserved.

ISSN 1931-3268 (print)
ISSN 1931-3209 (online)