FDA Expands Pediatric Indication for Rinvoq
By Lori Solomon HealthDay Reporter
FRIDAY, June 21, 2024 -- The U.S. Food and Drug Administration has expanded indications for Rinvoq (upadacitinib) to now include pediatric patients (ages 2 years and older) with polyarticular juvenile idiopathic arthritis (pJIA) and psoriatic arthritis (PsA).
Rinvoq is indicated for pediatric patients with an inadequate response or intolerance to one or more tumor necrosis factor (TNF) blockers. In addition, Rinvoq LQ, a new weight-based oral solution, is available for these pediatric patients.
The expanded indication is based on pharmacokinetic data from 51 patients with pJIA with active polyarthritis and safety data from 83 patients with pJIA with active polyarthritis. At the recommended doses, upadacitinib plasma exposures in pediatric patients with pJIA and PsA are expected to be comparable to those observed in adults with rheumatoid arthritis and PsA based on population pharmacokinetic modeling and simulation.
"Pediatric patients with pJIA and PsA can be severely limited in their ability to complete daily physical tasks and participate in everyday activities. Understanding their needs today and knowing the likelihood of disease in adulthood underscores the need for additional treatment options," Aarat Patel, M.D., from the Bon Secours Rheumatology Center of St. Mary’s Hospital in Richmond, Virginia, said in a statement. "Having a treatment option available for patients who do not respond well to a TNF inhibitor addresses a need for the health care community, patients, and their families."
Expanded approval of Rinvoq was granted to AbbVie.
Disclaimer: Statistical data in medical articles provide general trends and do not pertain to individuals. Individual factors can vary greatly. Always seek personalized medical advice for individual healthcare decisions.
© 2024 HealthDay. All rights reserved.
Posted June 2024
Read this next
Coexistence of Psoriatic Arthritis, Atopic Dermatitis May Offer Treatment Insights
MONDAY, May 13, 2024 -- Psoriatic arthritis (PsA) and atopic dermatitis (AD) can coexist, and the presence of both conditions may mean special attention should be given to...
Rheumatic Diseases Have an Impact on Reproductive Health
WEDNESDAY, April 3, 2024 -- Rheumatic diseases have a broad impact on reproductive success and pregnancy outcomes, according to a study published online March 20...
Model Predicts New Psoriatic Arthritis in People With Psoriasis
FRIDAY, Aug. 11, 2023 -- The development of psoriatic arthritis (PsA) can be predicted with reasonable accuracy for psoriasis patients, according to a study published online Aug...
More news resources
- FDA Medwatch Drug Alerts
- Daily MedNews
- News for Health Professionals
- New Drug Approvals
- New Drug Applications
- Drug Shortages
- Clinical Trial Results
- Generic Drug Approvals
Subscribe to our newsletter
Whatever your topic of interest, subscribe to our newsletters to get the best of Drugs.com in your inbox.