AbbVie has announced that its RINVOQ (upadacitinib) is now indicated for treating polyarticular juvenile idiopathic arthritis (pJIA) and psoriatic arthritis (PsA) in paediatric patients aged two years and above in the US.
RINVOQ is designed for children with pJIA and PsA who have shown an inadequate response or intolerance to one or more tumour necrosis factor blockers.
A new weight-based oral solution, RINVOQ LQ (upadacitinib), has also been made available for these paediatric populations.
The approvals are supported by controlled studies in adults, pharmacokinetic data and safety data from paediatric patients with active polyarthritis.
RINVOQ’s approval is based on data extrapolated from studies in adults with rheumatoid arthritis and PsA, as well as pharmacokinetic data from adult RA and PsA patients.
The findings also included data from 51 paediatric patients, and safety data from 83 paediatric patients aged two years to below 18 years with juvenile idiopathic arthritis with active polyarthritis.
The safety profile of RINVOQ/RINVOQ LQ observed in paediatric JIA patients with active polyarthritis was found to be in line with the known safety profile of RINVOQ in other indications.
RINVOQ is also being studied for a range of immune-mediated inflammatory diseases.
Ongoing Phase III trials are examining the asset for conditions including alopecia areata, ankylosing spondylitis, atopic dermatitis, axial spondyloarthritis, Crohn's disease, giant cell arteritis, hidradenitis suppurativa, psoriatic arthritis, rheumatoid arthritis, systemic lupus erythematosus (SLE), Takayasu arteritis, ulcerative colitis and vitiligo.
AbbVie global therapeutics senior vice-president and chief medical officer Roopal Thakkar stated: “RINVOQ has been an important addition to the treatment landscape for various rheumatic diseases, helping adult patients achieve meaningful disease control.
"AbbVie is proud to now offer RINVOQ as a tablet and oral solution to some of our youngest patients.”
In May 2024, the European Medicines Agency’s Committee for Medicinal Products for Human Use granted AbbVie’s ulcerative colitis drug Skyrizi (risankizumab) a recommendation for approval.
