FDA Broadens Rinvoq Use for Children

The U.S. Food and Drug Administration (FDA) has broadened the use of Rinvoq (upadacitinib) to include pediatric patients aged 2 years and older who suffer from polyarticular juvenile idiopathic arthritis (pJIA) and psoriatic arthritis (PsA). This expansion is specifically for young patients who have not responded adequately to or cannot tolerate one or more tumor necrosis factor (TNF) inhibitors. Additionally, a new weight-based oral solution, Rinvoq LQ, has been introduced for these pediatric patients.

The approval of this expanded indication is rooted in pharmacokinetic data from a study involving 51 patients with pJIA who had active polyarthritis, as well as safety data from 83 patients with the same condition. According to population pharmacokinetic modeling and simulation, the plasma levels of upadacitinib in pediatric patients with pJIA and PsA, when administered at recommended doses, are anticipated to be similar to those observed in adults with rheumatoid arthritis and PsA.

Dr. Aarat Patel, from the Bon Secours Rheumatology Center of St. Mary’s Hospital in Richmond, Virginia, emphasized the significance of this development. He noted that pediatric patients with pJIA and PsA often face severe limitations in performing daily activities and participating in normal childhood activities. Recognizing their needs today and understanding the potential progression of the disease into adulthood highlights the importance of having additional treatment options. Dr. Patel pointed out that having a viable treatment alternative for patients who do not respond well to a TNF inhibitor is a significant advancement for the healthcare community, as well as for patients and their families.

The FDA's expanded approval of Rinvoq is a noteworthy development for AbbVie, the pharmaceutical company responsible for the medication. This approval signifies a critical step forward in addressing the treatment needs of pediatric patients with these complex conditions.

This expanded indication and the introduction of Rinvoq LQ provide new hope for young patients and their families, offering an alternative when other treatment options have failed or are not well-tolerated.