The US Food and Drug Administration (FDA) has expanded the indication of AbbVie’s Rinvoq (upadacitinib) to include paediatric patients with active polyarticular juvenile idiopathic arthritis (pJIA) and psoriatic arthritis (PsA).
Children, aged two years and above in the US, are eligible for Rinvoq, provided they have not shown sufficient response to or cannot tolerate one or more tumour necrosis factor (TNF) blockers.
AbbVie has also announced the availability of a new weight-based oral solution, Rinvoq LQ (upadacitinib) for these paediatric patients.
The approval represents the first indication of the drug for paediatric patients two years of age and older. Rinvoq is now authorised for eight indications across immune-mediated inflammatory diseases.
RINVOQ and RINVOQ LQ oral solution have been approved by the FDA based on results from well-controlled studies in adults with rheumatoid arthritis (RA) and psoriatic arthritis (PsA), as well as pharmacokinetic data obtained from adults with RA and PsA.
The approvals were also based on the trial of 51 paediatric patients with juvenile idiopathic arthritis showing active polyarthritis.
Safety data from 83 paediatric patients aged two to less than 18 years with juvenile idiopathic arthritis and active polyarthritis also contributed to the approvals.
The safety profile noted in paediatric patients with active polyarthritis due to juvenile idiopathic arthritis, who were treated with Rinvoq/Rinvoq LQ, aligned with the established safety profile of the drug.
AbbVie senior vice president and global therapeutics chief medical officer Roopal Thakkar said: “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.”
The company said that Phase 3 trials are currently underway to evaluate Rinvoq in 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.
Last week, AbbVie received a positive opinion on approval of risankizumab (SKYRIZI) from the European Medicines Agency’s (EMA’s) Committee for Medicinal Products for Human Use (CHMP) for the treatment of ulcerative colitis.
