FDA approves Rinvoq for JIA, psoriatic arthritis in children aged 2 years and older
Click Here to Manage Email Alerts
Key takeaways:
- Children with active polyarticular JIA and PsA can use Rinvoq if they have inadequate response or intolerance to a TNF inhibitor.
- The drug is also available in a weight-based oral solution.
The FDA has expanded the indication of Rinvoq to include active, polyarticular juvenile idiopathic arthritis and psoriatic arthritis in children aged 2 years and older, according to an AbbVie press release.
The announcement represents the first indication of Rinvoq (upadacitinib, AbbVie) for pediatric patients aged 2 years and older, the company said. To use the drug under the new indication, patients must have inadequate response or intolerance to at least one TNF inhibitor.
“Pediatric patients with [polyarticular JIA] and PsA can be severely limited in their ability to complete daily physical tasks and participate in everyday activities,” Aarat Patel, MD, of the Bon Secours Rheumatology Center of St. Mary’s Hospital, in Richmond, Virginia, said in the release. “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.”
The drug is also now available in a weight-based oral solution, Rinvoq LQ (upadacitinib, AbbVie), for pediatric populations, according to the release.
“Rinvoq has been an important addition to the treatment landscape for various rheumatic diseases, helping adult patients achieve meaningful disease control,” Roopal Thakkar, MD, senior vice president and chief medical officer of global therapeutics at AbbVie, said in the release. “AbbVie is proud to now offer Rinvoq as a tablet and oral solution to some of our youngest patients.”
The approvals were based on studies of upadacitinib in adults with rheumatoid arthritis and PsA, as well as safety data from 83 children with JIA plus active polyarthritis, according to the release. Pharmacokinetic data from adults with RA and PsA, as well as 51 children with JIA plus active polyarthritis, also contributed to the approvals.
Read more about
Click Here to Manage Email Alerts